Patent Publication Number: US-7909038-B2

Title: Tongue stabilization device and methods of using the same

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     The present application is a continuation-in-part patent application of prior non-provisional U.S. patent application Ser. No. 11/737,107, filed Apr. 18, 2007 which claims priority to U.S. Provisional Patent Application No. 60/745,254, filed Apr. 20, 2006, the teachings of which are incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     Snoring is very common among mammals including humans. Snoring is a noise produced while breathing during sleep due to the 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. 
     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. 
     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. 
     Sleep apnea is diagnosed and treated by primary care physicians, 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. 
     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. 
     Continuous positive airway pressure (CPAP) is the most common treatment for sleep apnea. In this procedure, the patient wears a mask over the nose or mouth during sleep, and pressure from an air blower forces air through the air 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. CPAP prevents airway closure while in use, but apnea episodes return when CPAP is stopped or it is used improperly. Many variations of 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 devices vary the pressure to coincide with the person&#39;s breathing pattern, and other CPAP devices start with low pressure, slowly increasing it to allow the person to fall asleep before the full prescribed pressure is applied. 
     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. 
     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. 
     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. 
     Laser-assisted uvulopalatoplasty (LAUP) 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, LAUP 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. 
     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. 
     Tracheotomy 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. 
     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. 
     Recently, Restore Medical, Inc., Saint Paul, Minn. has developed a new treatment for snoring and apnea, called the Pillar technique. Pillar System involves a procedure where 3 or more small polyester rod devices are placed in the patient&#39;s soft palate. The Pillar System stiffens the palate, reduces vibration of the tissue, and prevents the possible airway collapse. Stiff implants in the soft palate, however, could hinder patient&#39;s normal functions like speech, ability to swallow, coughing and sneezing. Protrusion of the implant into the airway is another long-term concern. 
     As the current treatments for snoring and/or apnea are not effective and have side-effects, there is a need for additional treatment options. 
     BRIEF SUMMARY OF THE INVENTION 
     Methods and devices for the treatment of airway disorders, such as snoring and/or apnea are disclosed herein. In another embodiment, the present invention provides an implant for stabilizing the tongue. The implant includes a first anchoring portion for securing a first end of the implant with the mandibula; a control portion connected with the anchoring portion, configured for selectively activating the implant; a flexible portion connected at its proximal end with the control portion, the flexible portion having three-dimensional flexibility in a first state and the flexible portion having a lesser three-dimensional flexibility in a second state, the flexible portion being selectively switchable between the first and second state by the control portion; a second anchoring portion connected with an end of the flexible portion, the second anchoring portion being configured for connecting the implant with the base of the tongue; and a latch mechanism coupled with the control portion and configured to maintain the flexible portion in either of the first and second states. 
     In one aspect, the implant&#39;s first anchoring portion includes an anchoring bracket. 
     In another aspect, the control portion includes a shape memory member coupled with a flexible fiber, the fiber being connected at its proximal end with the shape memory member and the fiber being connected at its distal end with the distal end of the flexible portion, the flexible fiber being configured to impart an axial load on the flexible portion. 
     In another aspect, the latch mechanism is a normally closed latch mechanism, wherein the normally closed latch mechanism is configured to securely hold the flexible fiber when the latch mechanism is in a nonpowered state. 
     In one aspect, the latch mechanism includes a retainer ring coupled with a retainer ring engaging member that is coupled with the flexible fiber. 
     In another aspect, the latch mechanism also includes a shape memory material connected with the retainer ring. The shape memory material is configured to open the retainer ring when powered to release the retainer ring engaging member. 
     In another aspect, the latch mechanism includes a spring biased collet configured to securely hold the flexible fiber. 
     In one aspect, the spring-biased collet latch mechanism also includes a shape memory material connected with the collet, the shape memory material being configured to urge the spring-biased collet away from the collet&#39;s biased position when powered to release the flexible fiber from the collet. 
     In one aspect, the shape memory actuator member is made from a shape memory material configured to transition from a substantially martensitic phase to a substantially austenitic phase beginning at approximately 47 Deg. C. 
     In another aspect, the shape memory material is configured to experience a contraction when its temperature is elevated above approximately 47 Deg. C. And the shape memory material is configured to experience an expansion after the contraction when its temperature is lowered below approximately 52 Deg. C. 
     In another aspect, the control portion is powered by a non-implanted inductively coupled power source. 
     In another aspect, the flexible portion includes a flexible helical spring. 
     In another aspect, the flexible portion includes a bellows structure. 
     In another aspect, the flexible portion includes an etched stent-like portion. 
     In another aspect, the flexible portion is coated with a hyaluronic acid coating. 
     In another aspect, the second anchoring portion includes a first disc connected with the distal end of the flexible portion and a second disc connectable with the base of the tongue. 
     In one aspect, the first and second discs include suture holes disposed around their circumferences. 
     In another aspect, the first and second discs also include polyester rods having holes extending from the flat surfaces of the discs. 
     In another aspect, the second anchoring portion include a first proximally extending anchor portion and a second distally extending anchor portion. 
     In one aspect, the control portion includes a microprocessor. The microprocessor being adapted and configured to sense closing of the air passageway and controlling an energizing of the flexible portion. 
     In another aspect, the tongue implant device also includes a coating to prevent tissue in-growth. 
     In another aspect, the tongue implant device also includes a coating to promote tissue growth. 
     In one aspect, the tongue implant device also includes a sensor element, where the sensor is adapted and configured to monitor a condition of an airway to determine likelihood of an apneic event. The condition monitored can be an air passageway gap, air flow pressure, and/or wall tension. The device can also provide feedback to modulate the opening of the air passageway by the flexible portion. 
     In another embodiment, a method of treating a disease using an airway implant device is disclosed. The method involves implanting in a subject a device having a first anchoring portion for securing a first end of the implant with the mandibula; a control portion connected with the anchoring portion, configured for selectively activating the implant; a flexible portion connected at its proximal end with the control portion, the flexible portion having three-dimensional flexibility in a first state and the flexible portion having a lesser three-dimensional flexibility in a second state, the flexible portion being selectively switchable between the first and second state by the control portion; a second anchoring portion connected with the distal end of the flexible portion, the second anchoring portion being configured for connecting the implant with the base of the tongue; and a latch mechanism coupled with the control portion and configured to maintain the flexible portion in either of the first and second states, the device being adapted and configured to support the tongue upon being energized. The disease can be a sleep disorder. The sleeping disorder can be an obstructive sleep apnea or snoring. 
     For a further understanding of the nature and advantages of the invention, reference should be made to the following description taken in conjunction with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the embodiments of the present invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates one embodiment of the airway implant device. 
         FIG. 2  illustrates one embodiment of the airway implant device. 
         FIG. 3  illustrates one embodiment of the airway implant device. 
         FIG. 4  illustrates one embodiment of the airway implant device. 
         FIG. 5  illustrates a circuit diagram of an embodiment of the airway implant device. 
         FIG. 6  illustrates an embodiment of the airway implant device. 
         FIG. 7  illustrates a sectional view of an embodiment of the electroactive polymer element. 
         FIG. 8  illustrates a sectional view of an embodiment of the electroactive polymer element. 
         FIG. 9  illustrates an embodiment of the electroactive polymer element. 
         FIG. 10  illustrates an embodiment of the electroactive polymer element. 
         FIG. 11  illustrates an embodiment of the electroactive polymer element. 
         FIG. 12  illustrates an embodiment of the electroactive polymer element. 
         FIG. 13  illustrates an embodiment of the electroactive polymer element. 
         FIG. 14  illustrates an embodiment of the electroactive polymer element. 
         FIG. 15  illustrates an embodiment of the electroactive polymer element. 
         FIG. 16  illustrates an embodiment of the electroactive polymer element. 
         FIG. 17  illustrates an embodiment of the electroactive polymer element. 
         FIG. 18  illustrates an embodiment of the electroactive polymer element. 
         FIG. 19  illustrates an embodiment of the electroactive polymer element. 
         FIG. 20  illustrates an embodiment of the implanted portion of the airway implant device. 
         FIG. 21  illustrates an embodiment of the airway implant device. 
         FIG. 22  illustrates an embodiment of the non-implanted portion in the form of a mouth guard. 
         FIG. 23  illustrates an embodiment of the non-implanted portion in the form of a mouth guard. 
         FIG. 24  illustrates an embodiment of the non-implanted portion. 
         FIG. 25  shows a sagittal section through a head of a subject illustrating an embodiment of a method for using the airway implant device. 
         FIG. 26  illustrates an anterior view of the mouth with see-through mouth roofs to depict an embodiment of a method for using the airway implant device. 
         FIG. 27  illustrates an anterior view of the mouth with see-through mouth roofs to depict an embodiment of a method for using the airway implant device. 
         FIG. 28  illustrates an anterior view of the mouth with see-through mouth roofs to depict an embodiment of a method for using the airway implant device. 
         FIG. 29  illustrates an anterior view of the mouth with see-through mouth roofs to depict an embodiment of a method for using the airway implant device. 
         FIG. 30  illustrates an embodiment of an inductive coupling system associated with the airway implant device. 
         FIG. 31  illustrates an embodiment of the airway implant device. 
         FIG. 32  illustrates an embodiment of the airway implant device. 
         FIG. 33  illustrates an embodiment in which a patient wears the non-implanted portion of the device on the cheeks. 
         FIG. 34A-34B  illustrates an embodiment of a method of the invention with the airway implant in the soft palate. 
         FIG. 35A-35B  illustrates an embodiment of a method of the invention with the airway implants in the soft palate and lateral pharyngeal walls. 
         FIG. 36A-36B  illustrates an embodiment of a method of the invention with the airway implants in the lateral pharyngeal walls. 
         FIG. 37  depicts the progression of an apneic event. 
         FIG. 38  depicts an embodiment of an airway implant device with sensors in the soft palate and laryngeal wall. 
         FIG. 39  depicts the functioning of an airway implant device with sensors in the soft palate and laryngeal wall. 
         FIG. 40  depicts an embodiment of an airway implant device with a sensor in the laryngeal wall. 
         FIG. 41  depicts an example of controller suitable for use with an airway implant device. 
         FIG. 42  depicts an embodiment of an airway implant device. 
         FIG. 43A  depicts an embodiment of an airway implant device. 
         FIG. 43B  depicts an embodiment of the non-implantable portion of the airway implant device of  FIG. 43A . 
         FIG. 44  depicts an embodiment of an airway implant device. 
         FIG. 45A-D  depicts an embodiment of the deformable element. 
         FIG. 46  is a simplified drawing of an exemplary tongue implant device in accordance with one embodiment of the present invention shown implanted in the tongue. 
         FIG. 47  is photograph of an exemplary prototype tongue implant device in accordance with one embodiment of the present invention. 
         FIG. 48  is a simplified schematic drawing of an exemplary tongue implant device in accordance with another embodiment of the present invention. 
         FIG. 49  is a simplified schematic drawing of an exemplary tongue implant device in accordance with another embodiment of the present invention. 
         FIG. 50  illustrates the overall appearance of the implant of  FIG. 49 . 
         FIGS. 51A-D  illustrate one exemplary procedure for the placement of the tongue implant. 
         FIG. 52  illustrates one embodiment of the latch mechanism for the tongue implant. 
         FIG. 53  is a simplified drawing illustrating an exemplary tongue implant device in accordance with another embodiment of the present invention (the proximal bracket portion is not shown). 
         FIG. 54  is an exploded assembly view drawing corresponding to the implant of  FIG. 53 . 
         FIG. 55A  illustrates the collet latch in its normally-closed position, and  FIG. 55B  shows the collet latch in its open position. 
         FIG. 56  is a graph of the performance characteristic for the shape memory actuator material used in the tongue implant. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Devices and Methods 
     A first aspect of the invention is a device for the treatment of disorders associated with improper airway patency, such as snoring or sleep apnea. The device comprises of a deformable element to adjust the opening of the airway. In a preferred embodiment, the deformable element comprises of an electroactive polymer (EAP) element. The electroactive polymer element in the device assists in maintaining appropriate airway opening to treat the disorders. Typically, the EAP element provides support for the walls of an airway, when the walls collapse, and thus, completely or partially opens the airway. 
     The device functions by maintaining energized and non-energized configurations of the EAP element. In preferred embodiments, during sleep, the EAP element is energized with electricity to change its shape and thus modify the opening of the airway. Typically, in the non-energized configuration the EAP element is soft and in the energized configuration is stiffer. The EAP element of the device can have a pre-set non-energized configuration wherein it is substantially similar to the geometry of the patient&#39;s airway where the device is implanted. 
     In some embodiments, the device, in addition to the EAP element, includes an implantable transducer in electrical communication with the EAP element. A conductive lead connects the EAP element and the implantable transducer to the each other. The device of the present invention typically includes a power supply in electrical communication with the EAP element and/or the implantable transducer, such as a battery or a capacitor. The battery can be disposable or rechargeable. 
     Preferred embodiments of the invention include a non-implanted portion, such as a mouthpiece, to control the implanted EAP element. The mouthpiece is typically in conductive or inductive communication with an implantable transducer. In one embodiment, the mouthpiece is a dental retainer with an induction coil and a power source. The dental retainer can further comprise a pulse-width-modulation circuit. When a dental retainer is used it is preferably custom fit for the individual biological subject. If the implantable transducer is in inductive communication, it will typically include an inductive receiver, such as a coil. The implantable transducer can also include a conductive receiver, such as a dental filling, a dental implant, an implant in the oral cavity, an implant in the head or neck region. In one embodiment, the device includes a dermal patch with a coil, circuit and power source, in communication with the implantable transducer. The dermal patch can also include a pulse-width-modulation circuit. 
     Another aspect of the invention is a method to modulate air flow through airway passages. Such modulation is used in the treatment of diseases such as snoring and sleep apnea. One method of the invention is a method for modulating the airflow in airway passages by implanting in a patient a device comprising a deformable element and controlling the device by energizing the deformable element. The deformable element preferably comprises an electroactive polymer element. The deformable element can be controlled with a mouthpiece inserted into the mouth of the patient. The energizing is typically performed with the use of a power supply in electrical communication, either inductive communication or conductive communication, with the deformable element. A transducer can be used to energize the deformable element by placing it in electrical communication with the power supply. Depending on the condition being treated, the deformable element is placed in different locations such as soft palate, airway sidewall, uvula, pharynx wall, trachea wall, larynx wall, and/or nasal passage wall. 
     A preferred embodiment of the device of the present invention comprises an implantable deformable element; an implantable transducer; an implantable lead wire connecting the deformable element and the transducer; a removable transducer; and a removable power source; and wherein the deformable element comprises an electroactive polymer. 
     Electroactive polymer is a type of polymer that responds to electrical stimulation by physical deformation, change in tensile properties, and/or 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. 
     Suitable materials for the electroactive polymer element include, but are not limited to, an ion exchange polymer, an ion exchange polymer metal composite, an ionomer base material. In some embodiments, the electroactive polymer is perfluorinated polymer such as polytetrafluoroethylene, polyfluorosulfonic acid, perfluorosufonate, and polyvinylidene fluoride. Other suitable polymers include polyethylene, polypropylene, polystyrene, polyaniline, polyacrylonitrile, cellophane, cellulose, regenerated cellulose, cellulose acetate, polysulfone, polyurethane, polyvinyl alcohol, polyvinyl acetate, polyvinyl pyrrolidone. Typically, the electroactive polymer element includes a biocompatible conductive material such as platinum, gold, silver, palladium, copper, and/or carbon. 
     Suitable shapes of the electroactive polymer element include three dimensional shape, substantially rectangular, substantially triangular, substantially round, substantially trapezoidal, a flat strip, a rod, a cylindrical tube, an arch with uniform thickness or varying thickness, a shape with slots that are perpendicular to the axis, slots that are parallel to the longitudinal axis, a coil, perforations, and/or slots. 
     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® (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. The IPMC element can be formed into 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. 
     The electroactive polymer element has, in some embodiments, multiple layers of the electroactive polymer with or without an insulation layer separating the layers of the electroactive polymer. Suitable insulation layers include, but are not limited to, silicone, polyurethane, polyimide, nylon, polyester, polymethylmethacrylate, polyethylmethacrylate, neoprene, styrene butadiene styrene, or polyvinyl acetate. 
     In some embodiments, the deformable element, the entire device, or portions of the airway implant have a coating. The coating isolates the coated device from the body fluids and/or tissue either physically or electrically. The device can be coated to minimize tissue growth or promote tissue growth. Suitable coatings include poly-L-lysine, poly-D-lysine, polyethylene glycol, polypropylene, polyvinyl alcohol, polyvinylidene fluoride, polyvinyl acetate, hyaluronic acid, and/or methylmethacrylate. 
     Embodiments of the Device 
       FIG. 1  illustrates an airway implant system  2  that has a power supply  4 , a connecting element, such as a wire lead  14 , and a deformable element, such as an electroactive polymer element  8 . Suitable power supplies  4  are 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  typically has a power output of from about 1 mA to about 5 A, for example about 500 mA. 
     Instead of or in addition to wire lead  14 , the connecting element may be 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 is made from one or more conductive materials, such as copper. The connecting element is completely or partially insulated and/or protected by an insulator, for example polytetrafluoroethylene (PTFE). The insulator can be biocompatible. The power supply  4  is typically in electrical communication with the deformable element  8  through the connecting element. The connecting element is attached to an anode  10  and a cathode  12  on the power supply  4 . The connecting elements can be made from one or more sub-elements. 
     The deformable element  8  is preferably made from an electroactive polymer. Most preferably, the electroactive polymer is an ion exchange polymer metal composite (IPMC). The IPMC has a base polymer embedded, or otherwise appropriately mixed, with a metal. The IPMC base polymer is preferably perfluorinated 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. 
       FIG. 2  illustrates that the deformable element  8  can have multiple elements  8  and connecting elements  14  that all connect to a single power supply  4 . 
       FIG. 3  illustrates an airway implant system  2  with multiple power supplies  4  and connecting elements  14  that all connect to a single deformable element  8 . The airway implant system  2  can have any number and combination of deformable elements  8  connected to power supplies  4 . 
       FIG. 4  illustrates an embodiment with the connecting element having 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 . In this embodiment, the first receiver is a first inductor  18 . The first inductor  18  is typically 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 deformable element  8 . The connecting element  14  has multiple connecting elements  6 . 
       FIG. 5  illustrates that the airway implant device of the present invention can have an implanted portion  20  and a non-implanted portion  22 . In this embodiment, the implanted portion  20  is a closed circuit with the first inductor  18  in series with a first capacitor  24  and the deformable element  8 . The deformable element  8  is attached to the closed circuit of the implanted portion  20  by a first contact  26  and a second contact  28 . In some embodiments, the implanted portion has a resistor (not shown). The non-implanted portion  22  is a closed circuit. The non-implanted portion  22  has a second inductor  16  that is in series with a resistor  30 , the power supply  4 , and a second capacitor  32 . The capacitors, resistors, and, in-part, the inductors are representative of the electrical characteristics of the wire of the circuit and not necessarily representative of specific elements. The implanted portion  20  is within tissue and has a tissue surface  33  nearby. The non-implanted portion is in an insulation material  35 . An air interface  37  is between the tissue surface  33  and the insulation material  35 . 
       FIG. 6  illustrates an embodiment in which the first energy transfer element of the connecting element  14  is a first conductor  34 . The second energy transfer element of the connecting element  14  is a second conductor  36 . The first conductor  34  is 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  are plugs, sockets, conductive dental fillings, tooth caps, fake teeth, or any combination thereof. 
       FIG. 7  illustrates an embodiment in which the deformable element  8  is a multi-layered device. The deformable element  8  has a first EAP layer  38 , a second EAP layer  40 , and a third EAP layer  42 . The EAP layers  38 ,  40  and  42  are in contact with each other and not separated by an insulator. 
       FIG. 8  illustrates another embodiment in which the deformable element  8  has a first EAP layer  38  separated from a second EAP layer  40  by a first insulation layer  44 . A second insulation layer  46  separates the second EAP layer from the third EAP layer  42 . A third insulation layer  48  separates the third EAP layer from the fourth EAP layer  50 . Insulation material is preferably 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 are connected to the power supply  4 . 
       FIGS. 9-19  illustrate different suitable shapes for the deformable element  8 .  FIG. 9  illustrates a deformable element  8  with a substantially flat rectangular configuration. The deformable element  8  can have a width from about 2 mm to about 5 cm, for example about 1 cm.  FIG. 10  illustrates a deformable element  8  with an “S” or zig-zag shape.  FIG. 11  illustrates the deformable element  8  with an oval shape.  FIG. 12  illustrates a deformable element  8  with a substantially flat rectangular shape with slots  52  cut perpendicular to the longitudinal axis of the deformable element  8 . The slots  52  originate near the longitudinal axis of the deformable element  8 . The deformable element  8  has legs  54  extending away from the longitudinal axis.  FIG. 13  illustrates a deformable element  8  with slots  52  and legs  54  parallel with the longitudinal axis.  FIG. 14  illustrates a deformable element be configured as a quadrilateral, such as a trapezoid. The deformable element  8  has chamfered corners, as shown by radius.  FIG. 15  illustrates a deformable element  8  with apertures  55 , holes, perforations, or combinations thereof.  FIG. 16  illustrates a deformable element  8  with slots  52  and legs  54  extending from a side of the deformable element  8  perpendicular to the longitudinal axis.  FIG. 17  illustrates a deformable element  8  with a hollow cylinder, tube, or rod. The deformable element has an inner diameter  56 .  FIG. 18  illustrates an arched deformable element  8 . The arch has a radius of curvature  57  from about 1 cm to about 10 cm, for example about 4 cm. The deformable element  8  has a uniform thickness.  FIG. 19  illustrates an arched deformable element  8 . The deformable element  8  can have a varying thickness. A first thickness  58  is equal or greater than a second thickness  60 . 
       FIG. 20  illustrates an embodiment of the implanted portion of an airway implant with a coil-type inductor  18  connected by a wire lead  6  to the deformable element  8 . In another embodiment, as illustrated in  FIG. 21  the implanted portion has a conductive dental filling  62  in a tooth  64 . The dental filling  62  is previously implanted for reasons related or unrelated to using of the airway implant system. The dental filling  62  is electrically connected to the wire lead  6 . For example, a portion of the wire lead  6  is implanted in the tooth  64 , as shown by phantom line. The wire lead  6  is connected to the deformable element  8 . 
       FIG. 22  illustrates an embodiment of the non-implanted portion  22  with a mouthpiece, such as a retainer  66 . The retainer  66  is preferably custom configured to fit to the patient&#39;s mouth roof, or another part of the patient&#39;s mouth. The second transducer, such as second inductor  16 , is integral with, or attached to, the retainer  66 . The second inductor  16  is located in the retainer  66  so that during use the second inductor  16  is proximal with the first inductor  18 . The power supply  4 , such as a cell, is integral with, or attached to, the retainer  66 . The power supply  4  is in electrical communication with the second inductor  16 . In some embodiments, the retainer  66  has a pulse-width-modulation circuit.  FIG. 23  illustrates that the retainer  66  has one or more tooth sockets  68 . The tooth sockets  68  are preferably configured to receive teeth that have dental fillings. The tooth sockets  68  are electrically conductive in areas where they align with dental fillings when in use. The power supply  4  is connected with the tooth sockets  68  via the wire leads  6 . In the embodiment of  FIG. 24 , the non-implantable portion  22  has the second inductor  16  attached to a removably attachable patch  70 . The patch  70  is attached to the power supply  4 . The power supply  4  is in contact with the second inductor  16 . This embodiment can be, for example, located on the cheeks as shown on  FIG. 33  or any other suitable location. 
     Preferably, the airway implant device  2  discussed herein is used in combination with an inductive coupling system  900  such as depicted in  FIG. 30 .  FIG. 30  depicts an inductive coupling system that is suitable for controlling the airway implant device  2  which includes a connecting element  906  (which connects the electrical contacts (not shown) to the rest of the electrical system), a connector  901 , a energy source  322 , a sensor  903 , a timer  904 , and a controller  905 . The connector  901 , energy source  322 , sensor  903 , a timer  904 , and controller  905  are located in a housing disposed in a region outside or inside the body. 
     Two preferred embodiments of the airway implant device are shown in  FIGS. 31 and 32 . The device in  FIG. 31  includes the deformable element  8  connected to an anode  10  and cathode  12  and to the induction coil  18 . The device also includes a controller  90 , such as a microprocessor. The circuitry within the controller is not shown. The controller  90  picks up AC signals from the induction coil  18  and converts it to DC current. The controller  90  can also include a time delay circuit and/or a sensor. The sensor could sense the collapsing and/or narrowing of the airways and cause the device to energize the deformable element  8  and thus completely or partially open up the airway in which the device is implanted.  FIG. 32  shows an embodiment with anchors  91  located on the deformable element  8 . The implant can be anchored in a suitable location with the use of these anchors and sutures and/or surgical glue. 
       FIG. 42  depicts an embodiment of the invention. The airway implant device comprises of two units—an implant unit and a retainer unit. The implant unit is implanted in a patient and includes an IPMC actuator and a coil. The retainer unit is typically not implanted in the patient and can be worn by the patient prior to going to bed. This unit includes a coil, a battery, and a microcontroller. 
       FIG. 43A-B  depicts yet another embodiment of the invention.  FIG. 43A  is the implant unit, preferably for implantation proximal to or in an airway wall. The implant unit includes a deformable element  8 , an inductor  18  in the form of a coil, a controller  90 , and connecting elements  6 .  FIG. 43B  depicts the removable retainer with an inductor  16  and a retainer  66 . 
     The implants described herein are preferably implanted with a deployment tool. Typically, the implantation involves an incision, surgical cavitation, and/or affixing the implant. 
     Sensing and Actuation of Airway Implants 
     One embodiment of the invention is an airway implant device with a sensor for monitoring a condition prior to and/or during the occurrence of an apneic event. Preferably, the sensor monitors for blockage of an airway. The sensor senses the possible occurrence of an apneic event. This sensing of a possible apneic event is typically by sensing a decrease in the airway gap, a change in air pressure in the airway, or a change in air flow in the airway. A progressive decrease in the airway gap triggers the occurrence of an apneic event. Most preferably the sensor senses one or more events prior to the occurrence an apneic event and activates the airway implant to prevent the apneic event. In some embodiments, the airway implant device and the sensor are in the same unit. In other embodiments, the deformable element of the airway implant device is the sensor. In these embodiments, the deformable element acts as both a sensor and actuator. In yet other embodiments, the airway implant device and the sensor are in two or more separate units. 
       FIG. 37  depicts the occurrence of an apneic event due to the blockage of airway  3701  caused by the movement of the soft palate  84 .  FIG. 37A  shows the soft palate  84  position during normal breathing cycle. An airway gap  3803  is maintained between the soft palate  84  and the laryngeal wall  3804  to maintain airflow  3805 .  FIG. 37B  shows the position of the soft palate  84  just prior to the airway  3701  blockage. It can be seen that the gap  3803 ′ in this case is smaller than the gap  3803  in  FIG. 37A .  FIG. 37C  shows the soft palate  84  blocking the airway  3701 ′, leading to the occurrence of an apneic event. In one aspect of the invention, the event shown in  FIG. 37C  is prevented by taking preemptive action during occurrence of event depicted in  FIG. 37B . 
     One aspect of the invention is an airway implant device with a sensor for sensing the occurrence of apneic events and actuating the device. The invention also includes methods of use of such device. 
     One embodiment of an airway implant device with sensor is depicted in  FIG. 38 . Non-contact distance sensors  3801  and  3802  are mounted on the laryngeal wall  3804  and also on the soft palate  84  to sense the airway gap between the soft palate  84  and the laryngeal wall  3804 . One or more gap values are calibrated into a microcontroller controlling the airway implant device. The functioning of the airway implant device with a sensor is depicted in  FIG. 39 . During the occurrence of the apneic event the gap between the soft palate  84  and the laryngeal wall  3804  decreases. This gap information is continuously monitored by the airway implant device microcontroller. When the gap becomes smaller than a preset threshold value, the airway implant microcontroller actuates the airway implant, which stiffens the soft palate  84  and the gap between the soft palate  84  and the laryngeal walls  3804  increases. When this gap crosses an upper threshold, the microcontroller powers off the airway implant actuator. 
     In one embodiment, the operation of the device is as follows:
     a) A threshold gap is calibrated into the microcontroller which is present in the removable retainer of the device. This threshold gap corresponds to the gap  3803 ′ formed by the position of the soft palate with respect to the laryngeal wall as depicted in the  FIG. 37B , i.e., a distance at which an apneic event could be triggered or an apneic event occurs. This calibration can take place in real time or when the device is being installed.   b) The non-contact sensor constantly monitors the gap and the information is constantly analyzed by a program present in the microcontroller.   c) The airway implant actuator is in the off state (not powered state) as long as the threshold gap is not reached.   d) When the gap is equal to the threshold gap, the micro controller, powers on the airway implant actuator (on state). This leads to the stiffening of the airway implant actuator, which in-turn stiffens the soft palate.   e) This stiffening of the soft palate prevents the obstruction of the airway and modulates the occurrence of an apneic event.   f) When the gap becomes more than the threshold gap, the micro-controller turns off the airway implant actuator (off state).   

     Typically, an algorithm in the micro-controller controls the actuation of the actuator. An example of the algorithm is—
         if (gap&lt;threshold gap); {Voltage applied to airway implant actuator=high (on state)} or else {Voltage applied to the airway implant actuator=low (off state)}       

     Complex algorithms, such as adaptive algorithms, can also be used. The objective of the adaptive algorithm can be to selectively control the stiffness of the soft palate by varying the power applied to the airway implant actuator. 
     Another example of an algorithm to selectively control the stiffness of the soft palate is: 
     
       
         
           
               
               
             
               
                   
                   
               
             
            
               
                   
                 If (gap &lt; or = g) 
               
               
                   
                 {Apply full power to the airway implant actuator} 
               
               
                   
                 Else 
               
               
                   
                 If (gap =g1) 
               
               
                   
                 {Voltage applied to airway implant actuator = v1} 
               
               
                   
                 Else if (gap = g2) 
               
               
                   
                 {Voltage applied to airway implant actuator = v2} 
               
               
                   
                 Else if (gap =g3) 
               
               
                   
                 {Voltage applied to airway implant actuator =v3} 
               
               
                   
                 Note (g1, g2, g3 &gt; g) 
               
               
                   
                   
               
            
           
         
       
     
     An example of a controller to maintain a predetermined reference gap is shown is  FIG. 41 . The objective of this algorithm is to maintain an actual airway gap g act  as close to the reference airway gap g ref  as possible by controlling the airway implant device actuator. The actual airway gap between the soft palate and the laryngeal wall g act  is measured and this information is the output of the position sensor. This airway gap information is feedback to the microcontroller which has a controller algorithm embedded in it. In the microcontroller the g act  is compared to a g ref  and based on the difference between both, the Proportional Integral Derivative (PID) controller generates a controlling voltage which is supplied to the airway implant device. The PID controller can have fixed gains or can have the gains adaptively tuned based on system information. 
     In alternative embodiments, the sensor can be a wall tension sensor, an air pressure sensor, or an air flow monitoring sensor. In another embodiment, instead of fully turning the airway implant actuator on or off, the actual value of the airway gap can be used to selectively apply varying voltage to the airway implant actuator, hence selectively varying the stiffness of the soft palate. In yet another embodiment, if the airway implant actuator exhibits a lack of force retention over an extended period of time under DC voltage, a feedback control algorithm may be implemented in the microcontroller, which uses the sensory information provided by the sensors to control the stiffness of the soft palate by maintaining the force developed by the airway implant actuator. 
     Another embodiment of the invention is depicted in  FIG. 40 . In this embodiment, the wall tension sensed by the wall tension sensor  4001  implanted into the laryngeal wall  3804  is used as a threshold criterion for activating the airway implant actuator. A wall tension sensor can also be placed in a pharyngeal wall or other suitable airway wall. The sensors of this invention can be placed in an airway wall or proximal to an airway wall. 
     Some of the advantages of the use of an airway sensor with an airway implant device include: optimization of the power consumed by the airway implant device and hence extension of the life of the device; assistance in predicting the occurrence of apneic event, and hence selective activation of the device in order to minimize any patient discomfort; flexibility to use a feedback control system if required to compensate for any actuator irregularities; and possible configuration of the system to interact with an online data management system which will store different parameters related to apneic events for a patient. This system can be accessed by the doctor, other health care providers, and the insurance agency which will help them provide better diagnosis and understanding of the patient&#39;s condition. 
     In preferred embodiments, the airway gap is individually calculated and calibrated for each patient. This information can be stored in the microcontroller. The sensors are described herein mainly in the context of airway implant devices comprising of electroactive polymer actuators. The sensors can also be used with airway implant devices comprising other active actuators, i.e., actuators that can be turned on, off, or otherwise be controlled, such as magnets. The sensors can be used to activate, in-activate, and/or modulate magnets used in airway implant devices. Preferably, the sensors are in the form of a strip, but can be any other suitable shape for implantation. They are typically deployed with a needle with the help of a syringe. The sensor can be made with any suitable material. In preferred embodiments, the sensor is a smart material, such as an IPMC. The sensor is typically in connection with a microcontroller, which is preferably located in the retainer. This connection can be either physical or wireless. 
     Suitable sensors include, but are not limited to, an electroactive polymer like ionic polymer metal composite (IPMC). Suitable materials for IPMC include perfluorinated polymer such as polytetrafluoroethylene, polyfluorosulfonic acid, perfluorosulfonate, and polyvinylidene fluoride. Other suitable polymers include polyethylene, polypropylene, polystyrene, polyaniline, polyacrylonitrile, cellophane, cellulose, regenerated cellulose, cellulose acetate, polysulfone, polyurethane, polyvinyl acetate. Typically, the electroactive polymer element includes a biocompatible conductive material such as platinum, gold, silver, palladium, copper, and/or carbon. Commercially available materials suitable for use as a sensor include Nafion® (made by DuPont), Flemion® (made by Asahi Glass), Neosepta® (made by Astom Corporation), Ionac® (made by Sybron Chemicals Inc), Excellion™ (made by Electropure). Other materials suitable for use as a sensor include materials with piezoelectric properties like piezoceramics, electrostrictive polymers, conducting polymers, materials which change their resistance in response to applied strain or force (strain gauges) and elastomers. 
     The airway implant devices of the present invention, with or without the sensor, can be used to treat snoring. For snoring, the sensor can be adapted and configured to monitor air passageways so as to detect the possible occurrence of snoring or to detect the possible worsening of ongoing snoring. Preferably the sensors are capable of detecting relaxation of tissues in the throat, which can cause them to vibrate and obstruct the airway. Other tissues that can be monitored by the sensor include the mouth, the soft palate, the uvula, tonsils, and the tongue. 
     Another disease that can be treated with the devices of the present invention includes apnea. The sensor preferably monitors the throat tissue for sagging and/or relaxation to prevent the occurrence of an apneic event. Other tissues that can be monitored by the sensor include the mouth, the soft palate, the uvula, tonsils, and the tongue. 
     Airway Implant Device 
     One aspect of the invention is an airway implant device with a connecting element. Preferably the connecting element is used to anchor and/or support the airway implant device, in particular, the deformable element to a rigid structure, such as a bony structure. The invention also includes methods of treating a disease using an airway implant device by implanting in a subject the airway implant device having a deformable element and a connecting element, the implanting step including fastening the deformable element to a bony structure of the subject with the connecting element, wherein the deformable element is capable of modulating the opening of the air passageway. Another method is a method of treating a disease using an airway implant device by implanting a deformable element in a tongue of a subject and linking the deformable element to a jaw bone, the deformable element is capable of supporting the tongue when it is energized. The devices are used to treat sleeping disorders, such as obstructive sleep apnea or snoring. 
     One embodiment is an airway implant device having a deformable element and a connecting element, wherein the deformable element is capable of modulating the opening of an air passageway and the connecting element is used to fasten the deformable element to a rigid structure. Preferably, the rigid structure is a bony structure. The deformable element can be made of a magnetic material or an electroactive polymer element. In some embodiments, both the deformable element and connecting element are made from a polymeric material. In this embodiment, the polymeric material of the deformable element is typically an electroactive polymer. The electroactive polymer element can include an ion-exchange polymer metal composite. In other embodiments, the electroactive polymer element can include a conducting polymer such as a polypyrrole, a carbon nanotube or a polyaniline. 
     One embodiment of the airway implant device with a connecting element is depicted in  FIG. 44 . The deformable element  8  is linked to the jaw bone with a connecting element  4401 . A first inductor  18  is implanted in the patient and a second inductor  16  is located on the outside and can be worn by the patient when the airway implant device needs to be activated, for example prior to going to sleep. 
     The deformable element can have a suitable shape such as a flat surface or a tube. Preferably, the deformable element is adapted and configured to expand and contract like an accordion, in particular for an airway implant device that is used for implantation in the tongue. Examples of shapes of the deformable element  8  are depicted in  FIG. 45A-45D . These forms are particularly useful for implantation in the tongue.  FIG. 45A  depicts a deformable element  8  with a single layer  4501  of suitable material, such as an electroactive polymer or a magnetic material, with folds  4502 .  FIG. 45B  depicts a deformable element  8  with two layers  4501  and  4501 ′, joined by layers  4503  and  4503 ′ and folds  4502  and  4502 ′.  FIG. 45C  depicts a deformable element  8  with a series of layers  4504  which are connected to each other with a connecting element  4506 . The connecting element  4506  allows the layers  4504  to slide along its length. The connecting element  4506  and the layers  4504  can be made of the same material or different materials.  FIG. 45D  depicts a deformable element  8  with a series of layers  4504  which are held together at the connecting point  4505 . 
     In another embodiment, the airway implant device with the connecting element further includes an anode, a cathode, a first inductor, and a controller. The anode and cathode are typically connected to the deformable element. The controller typically comprises a microprocessor which is capable of sensing the opening of the air passageway and controlling the energizing of the deformable element. The deformable element is energized with a power supply. For example, when the deformable element is an electroactive polymer element, the power supply is in electrical communication with the deformable element and is activated by electrical energy from the power supply. The deformable element can be physically connected to the power supply for example with a wire lead or can be connected with an inductive coupling mechanism. 
     In an additional embodiment, the airway implant device with the connecting element further includes a sensor, as described herein. The sensor element is capable of monitoring a condition of an airway to determine likelihood of an apneic event. The condition being monitored is an air passageway gap, air flow pressure, and/or wall tension. The sensor can also provide feedback to modulate the opening of the air passageway by the deformable element. 
     The airway implant device with a connecting element further includes in some embodiments a non-implanted portion. Preferably the non-implanted portion is in the form of a strip and is used to control the deformable element. Typically this strip includes a power supply and a second inductor, the second inductor capable of interacting with a first inductor. 
     The connecting element can be used for implanting and/or for retrieving the deformable element, in addition to providing support to the organ being controlled by the airway implant. After implantation, the connecting element typically extends from deformable element to a rigid structure. The connecting element can include at one end an additional anchoring feature to assist with the anchoring to the rigid structure. The connecting element is preferably a wire made of nitinol, stainless steel, titanium or a polymer. The connecting element can be made from one or polymers, such as, for example, polyester or polyethylene; one or more superelastic metals or alloys, such as, for example, nitinol; or from resorbable synthetic materials, such as, for example suture material or polylactic acid. 
     As set forth above, certain embodiments of the present invention are related to an implantable device for stabilizing the tongue during sleeping. 
       FIG. 46  shows a simplified drawing of an exemplary tongue implant device in accordance with one embodiment of the present invention shown implanted in the tongue. As is shown in  FIG. 46 , reference number  5001  refers to the tongue; reference number  5002  refers to mandibula; reference number  5003  refers to the anchoring screws; reference number  5004  refers to an anchoring bracket; reference number  5005  refers to the power or actuation module; reference number  5006  refers to a flexible member, which in one embodiment can be a helix-shaped structure; reference number  5007  refers to the base of the tongue; and reference number  5008  refers to the anchor which can be an absorbable anchor. 
     As is shown in  FIG. 46 , the tongue implant can have three sections, namely: i) a proximal section that houses the powering mechanism  5005 , the actuation mechanism  5005  and the anchoring mechanism  5004  to the patient&#39;s mandibula, ii) a middle flexible section  5006  that links the actuation mechanism  5005  to the distal anchor  5008 , and iii) a distal anchor  5008 , which can be an absorbable anchor, that allows the implant to be anchored to the base of the tongue  5008 . The implant can be placed such that its proximal portion is anchored to the mandibula  5002  and its distal portion is anchored to the base of the tongue  5007 . 
     The Powering/Actuation portion  5005  and its housing can be anchored to the mandibula via a titanium bracket  5004  and titanium bone screws. The actuation mechanisms  5005  can include a Nitinol (actuator type) superelastic shape memory alloys, piezoelectric actuators, and/or electro active polymers, described below in further detail. 
     The actuator  5005  can be connected to the distal section via a flexible portion  5006  that in one embodiment can be made out of the same actuator material. Alternatively the middle flexible portion  5006  can be made from stainless steel, aramid fiber, polypropylene, nylon or any other suitable material. The flexible portion  5006  can also include a hyaluronic acid (HA) coating to prevent tissue in-growth. 
     The distal anchor  5008  can be made out of absorbable polymers such as polylactic acid, polyglycolic acid, and so on. Such materials would allow for better integration and anchoring of the implant at the base of the tongue muscle. 
       FIG. 47  shows a photograph of an exemplary prototype tongue implant device in accordance with one embodiment of the present invention. Shown in  FIG. 47  are the leads  5010  for powering the implant, the power/actuation portion  5012 , the flexible middle section  5014  and the distal anchor  5016 . It should be noted that the simple prototype device shown in  FIG. 47  is for testing purposes and thus the novel implant device is not limited to the prototype of  FIG. 47 . 
       FIG. 48  shows a simplified schematic drawing of an exemplary tongue implant device in accordance with another embodiment of the present invention. As shown in  FIG. 48 , the implant can include an anchor portion  5020  for securing the implant to the mandibula; a control portion  5022  for controlling the flexible portion  5024 ; a flexible portion  5024  and an anchor  5026  for securing the implant to the base of the tongue. As shown in  FIG. 48 , the actuation mechanism  5022  includes a small linear motor  5025  that is used to provide the linear actuation. For this purpose a Squiggle motor manufactured by New Scale Technologies can be used, but other suitable linear motors may also be used. Alternatively, in other embodiments, instead of motors other mechanisms such as smart active polymers/structures can also be used. As is shown in  FIG. 48 , the motor  5025  can be anchored to a titanium casing  5023  by using a combination of biocompatible epoxy and mechanical screw type anchoring through an internal anchoring mechanism  5027 . The device of  FIG. 48  can also have a guide mechanism  5028  which also incorporates a spring preload  5030 . In operation, the motor  5025  pushes against a stainless steel block  5032  which is guided by the thin guide rails  5028 . One or more springs  5030  can provide the pre-load against a fixed internal part  5029 , such that under no load condition the motor shaft has an axial load to displace linearly. The power transmission system  5021  can be attached on top of the titanium casing such that it can be as close to the outside of the chin as possible to effect an inductive power coupling. The titanium casing  5023  has two or more tapped holes  5034  for anchoring it with biocompatible screws to the mandibula. 
     The tongue stabilizing mechanism or the middle flexible portion  5024  provides for three-dimensional flexibility for the implant. When powered the flexible portion is stiffened along the central longitudinal axis to hold the tongue in position so as not to block the airway. When not powered, the middle flexible portion  5024  provides for three-dimensional flexibility for the implant, so as to enable the patient to have adequate tongue movement during speaking and swallowing. The middle flexible portion  5024  can include a flexible spring, bellows, etched stent or a combination of the three as the mechanism for supporting the tongue. The middle flexible portion can be coated with an HA coating for preventing tissue in-growth. An important functionality of this mechanism is to permit flexible movement of the tongue in all degrees of freedom during its non active (e.g. non-powered) state. And when the actuator is active, it can tighten the tongue and stabilize it, preventing its multiple degrees of freedom. A tough but flexible material such as a Kevlar fiber  5044  can be used to connect the moving end of the actuation mechanism  5032  to the end of the stabilizing mechanism such that when the actuator moves back it pulls the fiber and stiffens the spring or bellow. It too can be coated with HA coating for preventing tissue growth. 
     The anchoring mechanism  5026  can include two concentric polyester discs  5050 A- 5050 B with one  5050 A connected with the tongue stabilizing mechanism with suture holes around its circumference. The second disc  5050 B can also have suture holes  5056  around its circumference which are concentric with the holes in the first disc. Both discs can be connected by one or more polyester rods with holes  5052  for tissue in-growth. The disc further away from the middle flexible portion can be surgically inserted at the base of the tongue at a depth such that the second disc is in contact with the base of the tongue. The surgically implanted disc  5050 B can also have one or more polyester rods with polyester beads  5054  to facilitate good tissue in-growth and hence good anchoring. 
     The tongue implant device in accordance with the embodiments of the present invention can have may alternative configurations, including one or more of the following described embodiments. In a first embodiment the flexible middle portion  5022  can be actuated by a combination of a piezoelectric actuator and a linear motor coupled with a cable to stiffen a spring or bellow structure. In a second embodiment, the flexible middle portion  5022  can be actuated by a combination of a Nitinol or other shape memory material obviating the need for a linear motor and cable arrangement. In a third embodiment, the flexible middle portion  5022  can be actuated by combination of an electro active polymer such as polypyrrole, obviating the need for a linear motor and cable arrangement. Preferably, the Nitinol or the polypyrrole material are of a non-toxic medical grade type. Alternatively, the non-medical grade implant materials are encased or coated in medical grade materials. Such coatings can include a hyaluronic acid, or a poly-Lysine acid coating. The power source for the actuation of the implant device can be a non-implanted power source that is inductively coupled with the power-actuation portion of the tongue implant. 
       FIG. 49  is a simplified schematic drawing of an exemplary tongue implant device  5100  in accordance with another embodiment of the present invention.  FIG. 49  is shown as a longitudinal sectional drawing to better show the interior of the implant  5100 . The implant  5100  includes a bracket portion  5102  configured to be attached with the mandible. As is shown in  FIG. 49  the bracket portion  5102  includes a plurality of apertures that render the bracket  5102  more flexible so as to be bent into a shape that is suitable for attaching the bracket  5102  with a patient&#39;s mandible. The bracket  5102  can be an off-the shelf titanium or stainless steel bracket that are non-magnetic in nature. A housing portion  5104  is connected at the distal end of the bracket  5102 . The housing  5104  holds the actuation member  5106  for the deformable or the flexible portion  5108  of the implant  5100 . The housing  5104  can be made from a ceramic, a nylon, or a polymeric material such a polyphenylene sulfide (PPS). The housing  5104  serves to insulate and isolate the internal actuation member  5106  from the tongue tissue. The actuation member  5106  is a Nitinol actuator, or other shape memory actuator material, formed to have a helical shape. The Nitinol actuator is powered from the leads located at the proximal end  5107  of the actuation member  5106  using an inductively coupled power source as described above. The actuation member  5106  can be in the form of a double or triple or more helical members. The actuation member  5106  is insulated to avoid its forming a short circuit by making contact with itself when powered. The actuation member  5106  can be connected in parallel so as to have only two wires leading back to the proximal end  5107  of the actuation member  5106 . The actuation member  5106  is thermally activated by the resistive heating induced by an electric current flow. When the actuation member  5106  is activated, it heats up and contracts. When the actuation member  5106  is deactivated, it will cool down and relax back to its non-contracted state. This contraction/expansion of the actuation member  5106  is harnessed to act on flexible fiber  5110 . The fiber  5110  is connected at its proximal end with the distal end of the actuation member  5106 . The fiber  5110  is connected at its distal end with an end portion of the deformable portion  5108 . Fiber  5110  can be a Kevlar fiber, or any other suitable non-conducting material. 
     The distal end of the deformable portion  5110  is connected with an anchor member  5112 . The anchor  5112  need not be located at the distal end of the deformable portion  5110 ; it can be located at any length along the deformable portion. The anchor  5112  can be made from an absorbable material. The anchor  5112  is shown to have two sets of anchoring members  5113  and  5114 . The distal anchoring member  5113  is configured to prevent an unintended insertion of the implant beyond the desired location, which could cause an exposure of the implant into the oral cavity. The anchor  5112  is also configured to be deployable using a suitable deployment sheath, such a deployment sheath having peal-away portions. Distal tip  5115  is configured have a rounded and narrow shape to render the implant more easily deployable. The anchor  5112  shown in  FIG. 49  is an exemplary one and other anchoring configurations, such as those described above can also be employed. In addition, the anchor  5112  and members  5113  and  5114  can be perforated members to help induce a fibrosis if need be.  FIG. 50  illustrates the overall appearance of the implant  5100  of  FIG. 49 . 
     When the actuation member  5106  is activated, it will pull on fiber  5110  and reduce the flexibility of the deformable member  5108 . The tongue stabilizing mechanism or the middle flexible portion  5108  provides for three-dimensional flexibility for the implant. When powered the flexible portion is rendered less flexible along the central longitudinal axis to hold the tongue in position so as not to block the airway. When not powered, the middle flexible portion  5108  provides for three-dimensional flexibility for the implant, so as to enable the patient to have adequate tongue movement during speaking and swallowing. The middle flexible portion can be coated with an HA coating for preventing tissue in-growth. An important functionality of this mechanism is to permit flexible movement of the tongue in all degrees of freedom during its non active (e.g. non-powered) state. And when the actuator is active, it can stabilize the tongue, preventing its multiple degrees of freedom. The implant  5100  can be placed such that its proximal portion is anchored to the mandibula  5002  and its distal portion is anchored to the base of the tongue  5007 . The components located inside the housing can all be coated to render them more easily slidable inside the housing during the activation and deactivation of the implant. 
       FIGS. 51A-D  illustrate one exemplary procedure for the placement of the tongue implant. In  FIG. 51A , tongue tissue is dissected to make room in the form of a tongue cavity for the implant.  FIG. 51B  shows that the implant along with a peal-away introducer is inserted into the created cavity.  FIG. 51C  shows that introducer is pulled back and away. The removal of the sheath deploys the implant.  FIG. 51D . shows that in a last step, the bracket in the implant is anchored to the mandible. 
     Certain aspects of the tongue implant device are directed to a securing or latching mechanism to securely hold the fiber  5110 . The latching mechanism will enable the tongue implant to function without needing to be continually powered or activated. In one embodiment, the latching mechanism is configured to be normally closed, in other words the latch is closed when the implant is not powered. The closed latch hold the fiber  5110 . As described above, when the implant is powered by either the Nitinol actuator or the linear motor actuator or by way of any of the other actuators described above, a pulling force is imparted on the fiber that runs along the inside of the deformable section so as to reduce the deformable member&#39;s flexibility along its axial length. For the implant to remain in this mode, the pulling force needs to be maintained. One way of doing this requires the activation force to be constantly applied by way of constantly powering the implant. Another and more efficient way requires that the pulling force be maintained without having to continually power the implant. The function of the latch mechanism is to enable this functionality. In this normally closed configuration, when the implant is not powered and its deformable portion is in its less flexible mode, the normally closed latch will keep the implant in this less flexible mode. When the implant is powered to transition to its less flexible mode, first the latch is opened to allow the fiber to undergo a pulling action. Then once the flexible portion has completed its transition to its less flexible mode, the implant is unpowered. The unpowering will reset the latch to its closed position and thus maintain the implant in its less flexible mode. The latch mechanism can be made to be coupled with the housing portion. Further details of the operation of the latch mechanism are described below. 
       FIG. 52  illustrates one embodiment of the latch mechanism  5200 . This embodiment of the latch mechanism  5200  includes a retaining member  5206  coupled with the fiber  5110 . In the normally closed position, retainer ring  5204  is held against the retaining member  5206  to prevent the fiber  5110  from moving. When powered, the Nitinol wire or coil  5202  which is connected with the retainer ring  5204  is energized and thus pulls the retainer ring  5204  open allowing the retaining member  5206  and thus the fiber  5110  to move. 
       FIG. 53  is a simplified drawing illustrating an exemplary tongue implant device  5100  in accordance with another embodiment of the present invention (the proximal bracket or anchor portion  5102  is not shown). The implant  5100  includes a housing portion  5104  that houses the actuation and latching mechanisms. The housing portion  5104  is connected at its distal end with the deformable portion  5108 . As described above in connection with  FIG. 49 , the deformable portion  5108  is connected with the anchor  5112  having a distal anchor portion  5115  and a proximal anchor portion  5114 . The implant shown in  FIG. 53  includes two Nitinol activation coils. A first Nitinol coil  5302  is connected at its distal end with cable or fiber  5304 . The fiber  5304  extends through a hollow collet  5306  to the distal end of the deformable member  5108 . The activation or powering of first Nitinol member  5302  causes a pulling action on fiber  5304  which will render the deformable member  5108  less flexible along its longitudinal axis. A second Nitinol coil  5322  is connected at its distal end with cable or fiber  5324 . The fiber  5324  is connected at its distal end with the proximal end of the collet  5306 . The collet  5306  has a conical distal portion  5308  which is split into 2 or more (e.g. 3 or 4) portions which are dimensioned to securely hold the fiber  5304  when the distal portion  5308  is held against the complementarily-shaped conical recess in collet holder  5310 . The collet holder  5310  can have a recess at its distal end dimensioned to receive the deformable section  5108 . The collet  5306  is spring-biased by the collet spring  5312 . Collet spring  5312  is held in its biased position at its proximal end by resting against the housing shoulder  5313  and at its distal end by resting against collet shoulder  5315 . The activation of the second Nitinol coil  5322  causes a pulling action on the collet  5306 , lifting the collet&#39;s distal portion  5306  up and out of the distal end of the complementarily-shaped conical recess in collet holder  5310 , thus allowing the first fiber  5304  to be released from the collet&#39;s secure hold. Housing  5104  also includes collet guide portion  5326 . The collet guide portion  5326  of the housing  5104  is dimensioned to act as a bearing for the collet and thus guide the collet during its movement. In addition, the collet guide portion  5326  of the housing  5104  has a groove that is dimensioned to receive a complementarily-shaped key in the collet to also guide the movement of the collet  5306  in the housing  5104  and to prevent the rotation of the collet with respect to the housing and to prevent the tangling of the two Nitinol members  5302  and  5322  during the operation of the implant. Alternatively, the collet guide portion  5326  of the housing  5104  can have a key that is dimensioned to receive a complementarily-shaped groove in the collet to also guide the movement of the collet  5306  in the housing  5104  and to prevent the rotation of the collet with respect to the housing. 
     The sequence of operation for placing the implant of  FIG. 53  in its active mode is as follows. First the collet latch mechanism is activated to move and keep it in the unlocked position. Then the fiber pull mechanism is activated until sufficient flexibility in the deformable member has been removed. Then the latch mechanism is unpowered to have it return the collet to its spring-biased locked position. Then once the collet latch is in its normally closed position, the fiber pull mechanism is unpowered. The above sequence of operation is also applicable to the retaining member and retainer ring latch mechanism. 
     The sequence of operation for placing the implant of  FIG. 53  in its non-active mode is as follows. The latch mechanism is activated to move and keep it in the unlocked position. Then a subsequent tongue movement will extend and impart a slack to the fiber, returning the deformable portion to its deformable and flexible mode. The above sequence of operation is also applicable to the retaining member and retainer ring latch mechanism. 
       FIG. 54  is an exploded assembly view corresponding to the implant of  FIG. 53 .  FIG. 55A  illustrates the collet latch in its normally-closed position, and  FIG. 55B  shows the collet latch in its open position. The upward movement of the collet to its open position is arrested by the mating of the collet&#39;s proximal end against the shoulder portion  5328  of the housing. The housing, collet and collet holder can all be made from medical grade plastic materials and they can be coated with HA coating for preventing tissue in-growth. 
       FIG. 56  is a graph showing the performance characteristic for the shape memory actuator material used in the tongue implant. The shape memory material can be a shape memory alloy with a temperature-dependant phase transformation. The temperature at which the shape memory material changes its crystallographic structure, called transformation temperature, is characteristic of the alloy, and can be tuned by varying the elemental ratios in the alloy. This tuning of the transition temperature is known to those skilled in art and is disclosed in several issued U.S. patents, including for example U.S. Pat. Nos. 3,558,369; 4,310,354; and 4,505,767, the disclosures of which are hereby incorporated by reference herein. The shown performance characteristic of  FIG. 56  will be recognized as a material specification to those skilled in the art. In  FIG. 56 , the X-axis refers to the temperature in Deg. C. and the Y-axis refers to the percent Austenite or percent Martensite. A s  refers to the starting point for the change of phase from the martensitic phase to the austenitic phase. A f  refers to the point at which the change of phase from the martensitic phase to the austenitic phase has been completed. M s  refers to the starting point for the change of phase to the martensitic phase from the austenitic phase, and M f  refers to the point at which the change of phase from the austenitic phase to the martensitic phase has been completed. As can be seen in  FIG. 56 , the key phase transition points are as follows: A s  is approximately equal to 47° C.; A f  is approximately equal to 60° C.; M s  is approximately equal to 52° C., and M f  is approximately equal to 42° C. The above-mentioned transition temperatures can have a variation of ±2° C. 
     The operation of the shape memory actuator material in the tongue implant, starting from a nonpowered state is as follows. With the implant in the nonpowered state, the flexible portion of the implant is in it most flexible state. In this flexible state, the shape memory actuator and the implant are in thermal equilibrium with the body of the patient and thus are at approximately 37° C. Even in a patient experiencing high fever conditions (e.g. about 42° C.), the shape memory actuator material is still in its martensitic (uncontracted state). Once the device is powered, the resistive heating of the shape memory actuator material will cause its temperature to begin to rise, initially approaching A s  and continuing to A f . The transition in phase from the martensitic to the austenitic phase induced by the resistive heating of the shape memory actuator material will cause a pulling action on the flexible fiber and hence reduce the flexibility of the flexible portion of the implant. The transition time from the martensitic to the austenitic phase can take as long as a few minutes, but is most typically less than 2 minutes. The transition time can also be made extremely small by having an increase in the rate of current flow and its resulting resistive heating. Of course, a desired transition time will take patient comfort into account. The activated implant can then be held in place by the operation of the latch mechanism as described above. The latch mechanism also uses a shape memory actuator material that has the characteristic shown in  FIG. 56 . The use of the latch mechanism allows the implant to be in its less flexible state without the need to continuously power the implant. The continuous powering of the implant could cause a slight discomfort for the patient due to the warmer temperature of the shape memory actuator material in its contracted state. Accordingly, for a continuously powered implant the thermal insulating properties of the housing would require further consideration to minimize potential patient discomfort. In addition, the thermal insulation for the housing needs to be sufficiently low so as to not impede the cooling of the shape memory actuator material upon unpowering the implant. By not resistively heating the shape memory material actuator, it will cool down to M s  and begin its transition back to M f . The unheated or non-contracted shape memory material actuator does not impart a pulling force on the flexible portion of the implant. Likewise the unheated or non-contracted shape memory actuator material does not provide an opening force to the normally-closed latch mechanism. 
     The performance characteristic for the shape memory actuator material used in the tongue implant in accordance with  FIG. 56  is advantageous for several reasons. First, the transition from the martensitic to the austenitic phase occurs at a temperature range that is above a patient&#39;s normal body temperature. This is advantageous because it insures that the device does not get inadvertently activated, for example by a patient experiencing a high fever, or by a patient drinking a hot beverage. In addition, the inadvertent activation is also prevented by the presence of the latch mechanism. Second, the transition from the martensitic to the austenitic phase occurs over a rather narrow temperature range (e.g., less than 20° C.). This insures an effective implant operation in the expected range of temperatures; the implant does not get inadvertently activated, and the implant will remain in its non-activated state in a patient having a normal body temperature range. The normal body temperature as used herein includes a patient experiencing chilled (e.g. in an operating room) or an elevated temperature (e.g. fever). Furthermore, the temperature range for the transition from the martensitic to the austenitic phase and back insures that the implant will have a high fatigue rating, insuring that the implant will have an adequate operational life. 
     Methods of Making Electroactive Polymer Element 
     In some embodiments, the EAP element is an IPMC strip which is made from a base material of an ionomer sheet, film or membrane. The ionomer sheet is formed using ionomer dispersion. 
     IPMC is made from the base ionomer of, for example, polyethylene, polystyrene, polytetrafluoroethylene, polyvinylidene fluoride (PVDF) (e.g., KYNAR® and KYNAR Flex®, from ATOFINA, Paris, France, and SOLEF®, from Solvay Solexis S.A., Brussels, Belgium), hydrophilic-PVDF (h-PVDF), polyfluorosulfonic acid based membranes like NAFION® (from E.I. Du Point 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 is deposited on the ionomer either by electrolysis process, vapor deposition, sputtering, electroplating, or combination of processes. 
     The IPMC is cut into the desired implant shape for the EAP element. The electrical contact (e.g., anode and cathode wires for EAP element) is connected to the IPMC surfaces by, for example, soldering, welding, brazing, potting using conductive adhesives, or combinations thereof. The EAP element is configured, if necessary, into specific curved shapes using mold and heat setting processes. 
     In some embodiments, the EAP element is insulated with electrical insulation coatings. Also, the EAP element can be insulated with coatings that promote cell growth and minimize fibrosis, stop cell growth, or kill nearby cells. The insulation can be a biocompatible material. The EAP element is coated with polymers such as polypropylene, poly-L-lysine, poly-D-lysine, polyethylene glycol, polyvinyl alcohol, polyvinyl acetate, polymethyl methacrylate, or combinations thereof. The EAP element can also be coated with hyaluronic acid. The coating is applied to the device by standard coating techniques like spraying, electrostatic spraying, brushing, vapor deposition, dipping, etc. 
     In one example, a perfluorosulfonate ionomer, PVDF or h-PVDF sheet is prepared for manufacturing the EAP element. In an optional step, the sheet is roughened on both sides using, for example, about 320 grit sand paper and then about 600 grit sand paper; then rinsed with deionized water; then submerged in isopropyl alcohol (IPA); subjected to an ultrasonic bath for about 10 minutes; and then the sheet is rinsed with deionized water. The sheet is boiled for about 30 minutes in hydrochloric acid (HCL). The sheet is rinsed and then boiled in deionized water for about 30 minutes. The sheet is then subject to ion-exchange (i.e., absorption). The sheet is 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 typically has a concentration of greater than or equal to about 200 mg/100 ml water. 5% ammonium hydroxide solution is added at a ratio of 2.5 ml/100 ml to the tetraammineplatinum chloride solution to neutralize the solution. The sheet is then rinsed with deionized water. Primary plating is then applied to the sheet. The sheet is submerged in water at about 40° C. 5% solution by weight of sodium borohydride and deionized water is added to the water submerging the sheet at 2 ml/180 ml of water. The solution is stirred for 30 minutes at 40° C. The sodium borohydride solution is then added to the water at 2 ml/180 ml of water and the solution is stirred for 30 minutes at 40° C. This sodium borohydride adding and solution stirring is performed six times total. The water temperature is then gradually raised to 60° C. 20 ml of the sodium borohydride solution is then added to the water. The solution is stirred for about 90 minutes. The sheet is then rinsed with deionized water, submerged into 0.1N HCI for an hour, and then rinsed with deionized water. 
     In some embodiments, the sheet receives second plating. The sheet is submerged or otherwise exposed to a tetraammineplatinum chloride solution at a concentration of about 50 mg/100 ml deionized water. 5% ammonium hydroxide solution is added at a rate of 2 ml/100 ml of tetraammineplatinum chloride solution. 5% by volume solution of hydroxylamine hydrochloride in deionized water is added to the tetraammineplantinum 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 is added to the tetraammineplatinum chloride solution at a ratio of 0.05 of the volume of the tetraammineplantinum chloride solution. The temperature is then set to about 40° C. and the solution is stirred. 
     A 5% solution of hydroxylamine hydrochloride is then added at a ratio of 2.5 m/100 ml of tetraammineplatinum chloride solution. A 20% solution of hydrazine monohydrate solution is then added at a ratio of 1.25 ml/100 ml tetraammineplatinum chloride solution. The solution is stirred for 30 minutes and the temperature set to 60° C. The above steps in this paragraph can be repeated three additional times. The sheet is then rinsed with deionized water, boiled in HCl for 10 minutes, rinsed with deionized water and dried. 
     In some embodiments, the polymer base is dissolved in solvents, for example dimethyl acetamide, acetone, methylethyle ketone, toluene, dimethyl carbonate, diethyl carbonate, and combinations thereof. The solvent is then allowed to dry, producing a thin film. While the solution is wet, a low friction, (e.g., glass, Teflon) plate is dipped into the solution and removed. The coating on the plate dries, creating a think film. The plate is repeatedly dipped into the solution to increase the thickness of the film. 
     Polyvinyl alcohol, polyvinyl pyrrolidone, polyinyl 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 
       FIG. 25  illustrates an embodiment of a method of the airway implant device of the present invention. In this embodiment, the first inductor  18  is implanted in the mouth roof  72 , for example in or adjacent to the hard palate  74 . Wire leads  6  connect the first inductor  18  to the deformable elements  8   a ,  8   b , and  8   c . A first deformable element  8   a  is implanted in the base of the tongue at the pharynx wall  76 . A second deformable element  8   b  is integral with the first deformable element  8   a  (e.g., as two sections of a hollow cylindrical deformable element  8 , such as shown in  FIG. 17 ). The first and second deformable elements  8   a  and  8   b  can be separate and unattached elements. The third deformable element  8   c  is implanted in the uvula and/or soft palate  84 . The deformable 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. The second inductor  16  is worn by the patient in the mouth  82 . The second inductor  16  is connected to an integral or non-integral power supply. The second inductor  16  comprises one or multiple induction coils. The second inductor  16  inductively transmits RF energy to the first inductor  18 . The first inductor  18  changes the RF energy into electricity. The first inductor  18  sends a charge or current along the wire leads  6  to the deformable elements  8   a ,  8   b , and  8   c . The deformable elements  8   a ,  8   b , and  8   c  are energized by the charge or current. The energized deformable elements  8   a ,  8   b , and  8   c  increase the stiffness and/or alter the shape of the airways. The energized deformable elements  8   a ,  8   b , and  8   c  modulate the opening of the airways around which the deformable elements  8   a ,  8   b , and  8   c  are implanted. The non-energized deformable elements  8   a ,  8   b , and  8   c  are configured to conform to the airway around which the deformable elements  8   a ,  8   b , and  8   c  are implanted. The non-energized deformable elements  8   a ,  8   b , and  8   c  are flexible and soft. 
       FIG. 26  illustrates another embodiment of the invention. In this embodiment, the first inductor  18  is implanted in the mouth roof  72  and attached to a deformable element  8  via the wire lead  6 . The deformable element  8  is preferably in the soft palate  84 . In another embodiment,  FIG. 27  illustrates that the first inductor  18  is implanted in the mouth roof  72  and attached to two deformable elements  8  via two wire leads  6 . The deformable elements  8  are implanted in side walls  86  of the mouth  82 . In yet another embodiment, as illustrated in  FIG. 28 , the first inductor  18  is implanted in the mouth roof  72  and attached to three deformable elements  8  via three wire leads  6 . The deformable elements  8  are implanted in the soft palate  84  and the side walls  86  of the mouth  82 .  FIG. 29  illustrates an embodiment in which the first conductors (not shown, e.g., the tooth sockets), are attached to, and in conductive electrical communication with, the second conductors. The retainer  66 , such as shown in  FIG. 23 , can be worn by the patient to energize the deformable element  8 . The tooth sockets are removably attached to the first conductors  34 . The first conductors  34  are dental fillings, conductive posts adjacent to and/or through the teeth  64 . 
       FIG. 33  illustrates an embodiment in which a patient  88  has the first transducer (not shown) implanted in the patient&#39;s cheek and wears the non-implanted portion  22 , such as shown in  FIG. 24 , on the outside of the patient&#39;s cheek. The non-implanted portion  22  energizes the implanted portion (not shown). 
       FIGS. 34-36  depict some of the ways in which the implant devices function to open the airways.  FIGS. 34A and 34B  depict a side view of a patient with a soft palate implant  8   c  and a non-implanted portion of the device, with a second inductor  16 , which in this case is a wearable mouth piece. The wearable mouth piece includes a transmitter coil, a power source, and other electronics, which are not depicted. Also, shown is a first inductor  18 . The implant device has the ability to sense and deflect the tongue so as to open the airway.  FIG. 34A  depicts the tongue  92  in its normal state. During sleep, when the tongue collapses  92 ′, as shown in  FIG. 34B , the deformable element  8   c ′ senses the collapsed tongue and is energized via the mouthpiece and first inductor and it stiffens to push away the tongue from the airway and keeps the airway open. This opening of the airway can be partial or complete. In some embodiments, particularly the embodiments without the sensor, the implant is powered when the patient is asleep such that the deformable element  8  is energized and keeps the collapsed tongue away from the airway. 
       FIGS. 35 and 36  depict an embodiment of keeping the airways open with lateral wall implants.  FIG. 35A  shows a side view of a patient&#39;s face with a deformable element  8  located in the lateral wall of the airway.  FIG. 35A  depicts the tongue  92  in its normal state.  FIG. 35B  depicts the tongue  92 ′ in a collapsed state. When the tongue is in this state or before it goes into the collapsed state the deformable element  8  is energized so as to stretch the lateral walls and open the airway, as shown in  FIG. 36B .  FIGS. 36A and 36B  are a view of the airway as seen through the mouth of patient.  FIG. 36  A depicts the deformable elements  8  in a non-energized state and the tongue in a non-collapsed state. When the tongue collapses or it has a tendency to collapse, such as during sleep, the deformable element  8  is energized and airway walls are pushed away from the tongue and creates an open air passageway  93 . This embodiment is particularly useful in obese patients. 
     Airway Diseases 
     During sleep, the muscles in the roof of the mouth (soft palate), tongue and throat relax. If the tissues in the throat relax enough, they vibrate and may partially obstruct the airway. The more narrowed the airway, the more forceful the airflow becomes. Tissue vibration increases, and snoring grows louder. Having a low, thick soft palate or enlarged tonsils or tissues in the back of the throat (adenoids) can narrow the airway. Likewise, if the triangular piece of tissue hanging from the soft palate (uvula) is elongated, airflow can be obstructed and vibration increased. Being overweight contributes to narrowing of throat tissues. Chronic nasal congestion or a crooked partition between the nostrils (deviated nasal septum) may be to blame. 
     Snoring may also be associated with sleep apnea. In this serious condition, excessive sagging of throat tissues causes your airway to collapse, preventing breathing. Sleep apnea generally breaks up loud snoring with 10 seconds or more of silence. Eventually, the lack of oxygen and an increase in carbon dioxide signal causes the person to wake up, forcing the airway open with a loud snort. 
     Obstructive sleep apnea occurs when the muscles in the back of the throat relax. These muscles support the soft palate, uvula, tonsils and tongue. When the muscles relax, the airway is narrowed or closed during breathing in, and breathing is momentarily cut off. This lowers the level of oxygen in the blood. The brain senses this decrease and briefly rouses the person from sleep so that the airway can be reopened. Typically, this awakening is so brief that it cannot be remembered. Central sleep apnea, which is far less common, occurs when the brain fails to transmit signals to the breathing muscles. 
     Thus, it can be seen that airway disorders, such as sleep apnea and snoring, are caused by improper opening of the airway passageways. The devices and methods described herein are suitable for the treatment of disorders caused by the improper opening of the air passageways. The devices can be implanted in any suitable location such as to open up the airways. The opening of the passageways need not be a complete opening and in some conditions a partial opening is sufficient to treat the disorder. 
     In addition to air passageway disorders, the implants disclosed herein are suitable for use in other disorders. The disorders treated with the devices include those that are caused by improper opening and/or closing of passageways in the body, such as various locations of the gastro-intestinal tract or blood vessels. The implantation of the devices are suitable for supporting walls of passageways The devices can be implanted in the walls of the gastro-intestinal tract, such as the esophagus to treat acid reflux. The gastro-intestinal tract or blood vessel devices can be used in combination with the sensors described above. Also, the implants and/or sphincters can be used for disorders of fecal and urinary sphincters. Further, the implants of the invention can be tailored for specific patient needs. 
     As will be understood by those skilled in the art, the present invention may be embodied in other specific forms without departing from the essential characteristics thereof. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the following claims.