Airway implant and methods of making and using

Abstract

A system and device for maintaining and/or creating patency in airways is disclosed. The methods of using the system and device are also disclosed. The system includes a power source that energizes a electro-active polymer implant. The energized polymer implant provides stiffness and shape to the airway, thereby minimizing collapse or deformation of the airway. A method of making the device is also disclosed.

1 . An implantable device for maintaining and/or creating airway patency of a biological subject, comprising:
 a patency element that changes shape in response to an electrical stimulus and comprises an electro-active polymer.   
     
     
         2 . The device of  claim 1 , wherein the electro-active polymer comprises an ion exchange polymer. 
     
     
         3 . The device of  claim 1 , wherein the electro-active polymer comprises an ion exchange polymer metal composite. 
     
     
         4 . The device of  claim 1 , wherein the electro-active polymer comprises an ionomer base material. 
     
     
         5 . The device of  claim 1 , wherein the electro-active polymer comprises perfluorinated polymer. 
     
     
         6 . The device of  claim 1 , wherein the electro-active polymer comprises polytetrafluoroethylene. 
     
     
         7 . The device of  claim 1 , wherein the electro-active polymer comprises polyfluorosulfonic acid. 
     
     
         8 . The device of  claim 1 , wherein the electro-active polymer comprises perfluorosulfonate. 
     
     
         9 . The device of  claim 1 , wherein the electro-active polymer comprises polyvinylidene fluoride. 
     
     
         10 . The device of  claim 1 , wherein the electro-active polymer comprises hydrophilic polyvinylidene fluoride. 
     
     
         11 . The device of  claim 1 , wherein the electro-active polymer comprises polyethylene. 
     
     
         12 . The device of  claim 1 , wherein the electro-active polymer comprises polypropylene. 
     
     
         13 . The device of  claim 1 , wherein the electro-active polymer comprises polystyrene. 
     
     
         14 . The device of  claim 1 , wherein the electro-active polymer comprises polyaniline. 
     
     
         15 . The device of  claim 1 , wherein the electro-active polymer comprises polyacrylonitrile. 
     
     
         16 . The device of  claim 1 , wherein the electro-active polymer comprises cellophane. 
     
     
         17 . The device of  claim 1 , wherein the electro-active polymer comprises cellulose. 
     
     
         18 . The device of  claim 1 , wherein the electro-active polymer comprises regenerated cellulose. 
     
     
         19 . The device of  claim 1 , wherein the electro-active polymer comprises cellulose acetate. 
     
     
         20 . The device of  claim 1 , wherein the electro-active polymer comprises polysulfone. 
     
     
         21 . The device of  claim 1 , wherein the electro-active polymer comprises polyurethane. 
     
     
         22 . The device of  claim 1 , wherein the electro-active polymer comprises polyvinyl alcohol. 
     
     
         23 . The device of  claim 1 , wherein the electro-active polymer comprises polyvinyl acetate. 
     
     
         24 . The device of  claim 1 , wherein the electro-active polymer comprises polyvinyl pyrrolidone. 
     
     
         25 . The device of  claim 1 , wherein the electro-active polymer comprises a biocompatible conductive material. 
     
     
         26 . The device of  claim 25 , wherein the biocompatible conductive material comprises platinum. 
     
     
         27 . The device of  claim 25 , wherein the biocompatible conductive material comprises gold. 
     
     
         28 . The device of  claim 25 , wherein the biocompatible conductive material comprises silver. 
     
     
         29 . The device of  claim 25 , wherein the biocompatible conductive material comprises palladium. 
     
     
         30 . The device of  claim 25 , wherein the biocompatible conductive material comprises copper. 
     
     
         31 . The device of  claim 25 , wherein the biocompatible conductive material comprises carbon. 
     
     
         32 . The device of  claim 1 , wherein the patency element comprises a three dimensional shape. 
     
     
         33 . The device of  claim 1 , wherein the patency element comprises a substantially rectangular shape. 
     
     
         34 . The device of  claim 1 , wherein the patency element comprises a substantially triangular shape. 
     
     
         34 . The device of  claim 1 , wherein the patency element comprises a substantially round shape. 
     
     
         35 . The device of  claim 1 , wherein the patency element comprises a substantially trapezoidal shape. 
     
     
         36 . The device of  claim 1 , wherein the patency element comprises a shape slots that are perpendicular to the axis. 
     
     
         37 . The device of  claim 1 , wherein the patency element comprises slots that are parallel to the longitudinal axis. 
     
     
         38 . The device of  claim 1 , wherein the patency element comprises a flat strip. 
     
     
         39 . The device of  claim 1 , wherein the patency element comprises a rod. 
     
     
         40 . The device of  claim 1 , wherein the patency element comprises a cylindrical tube. 
     
     
         41 . The device of  claim 1 , wherein the patency element comprises an arch. 
     
     
         42 . The device of  claim 42 , wherein the arch has a uniform thickness. 
     
     
         43 . The device of  claim 42 , wherein the arch has a varying thickness. 
     
     
         44 . The device of  claim 1 , wherein the patency element comprises a coil. 
     
     
         45 . The device of  claim 1 , wherein the patency element comprises perforations. 
     
     
         46 . The device of  claim 1 , wherein the patency element comprises slots. 
     
     
         47 . The device of  claim 1 , wherein the patency element comprises a first layer of the electroactive polymer. 
     
     
         48 . The device of  claim 48 , wherein the patency element comprises a second layer of the electroactive polymer. 
     
     
         49 . The device of  claim 48 , wherein the patency element comprises an insulation layer separating the first layer of the electroactive polymer from the second layer of the electroactive polymer. 
     
     
         50 . The device of  claim 50 , wherein the insulation layer comprises silicone. 
     
     
         51 . The device of  claim 50 , wherein the insulation layer comprises polyurethane. 
     
     
         52 . The device of  claim 50 , wherein the insulation layer comprises polyimide. 
     
     
         53 . The device of  claim 50 , wherein the insulation layer comprises nylon. 
     
     
         54 . The device of  claim 50 , wherein the insulation layer comprises polyester. 
     
     
         55 . The device of  claim 50 , wherein the insulation layer comprises polymethylmethacrylate. 
     
     
         56 . The device of  claim 50 , wherein the insulation layer comprises polymethylmethacrylate. 
     
     
         57 . The device of  claim 50 , wherein the insulation layer comprises neoprene. 
     
     
         58 . The device of  claim 50 , wherein the insulation layer comprises styrene butadiene styrene. 
     
     
         59 . The device of  claim 50 , wherein the insulation layer comprises polyvinyl acetate. 
     
     
         60 . The device of  claim 1 , wherein the patency element has a non-energized configuration, and wherein the patency element is soft in the non-energized configuration. 
     
     
         61 . The device of  claim 1 , wherein the patency element has an energized configuration, and wherein the patency element in the energized configuration is stiffer than the patency element in the non-energized configuration. 
     
     
         62 . The device of  claim 1 , wherein the patency element has a pre-set non-energized configuration, and wherein the patency element is soft in the pre-set non-energized configuration. 
     
     
         63 . The device of  claim 63 , wherein the pre-set non-energized configuration is substantially similar to the geometry of the patient's airway where the device is implanted. 
     
     
         64 . The device of  claim 64 , wherein the patency element has a pre-set energized configuration when the patency element is energized, and wherein the patency element in the pre-set energized configuration is stiffer than the patency element in the pre-set non-energized configuration. 
     
     
         65 . The device of  claim 63 , wherein the patency element in the pre-set non-energized configuration is substantially equal to the patency element in the energized configuration. 
     
     
         66 . The device of  claim 66 , wherein the pre-set non-energized configuration is substantially similar to the geometry of the airway where the device is implanted. 
     
     
         67 . The device of  claim 1 , wherein the patency element comprises a coating. 
     
     
         68 . The device of  claim 68 , wherein the coating isolates the patency element from body fluids. 
     
     
         69 . The device of  claim 68 , wherein the coating's dielectric strength is sufficient enough to electrically isolate the patency element. 
     
     
         70 . The device of  claim 68 , wherein the coating is configured to minimize tissue growth on the patency element. 
     
     
         71 . The device of  claim 68 , wherein the coating is configured to promote tissue growth on the patency element. 
     
     
         72 . The device of  claim 68 , wherein the coating comprises poly-L-lysine. 
     
     
         73 . The device of  claim 68 , wherein the coating comprises poly-D-lysine. 
     
     
         74 . The device of  claim 68 , wherein the coating comprises polyethylene glycol. 
     
     
         75 . The device of  claim 68 , wherein the coating comprises polyvinyl alcohol. 
     
     
         76 . The device of  claim 68 , wherein the coating comprises polyvinyl acetate. 
     
     
         77 . The device of  claim 68 , wherein the coating comprises hyaluronic acid. 
     
     
         78 . The device of  claim 68 , wherein the coating comprises methylmethacrylate. 
     
     
         79 . An implantable device for maintaining and/or creating patency of a lumen of a biological subject, comprising:
 an electro-active patency element; and   an implantable transducer in electrical communication with the patency element.   
     
     
         80 . The device of  claim 80 , wherein the lumen comprises an airway. 
     
     
         81 . The device of  claim 80 , wherein the patency element comprises an electro-active polymer. 
     
     
         82 . The device of  claim 82 , wherein the electro-active polymer comprises an ion exchange polymer-metal composite. 
     
     
         83 . The device of  claim 80 , further comprising a conductive lead attached to the electroactive patency element and the implantable transducer. 
     
     
         84 . The device of  claim 80 , further comprising a conductive lead in electrical communication with the electro-active patency element and the implantable transducer. 
     
     
         85 . The device of  claim 80 , further comprising a power supply in electrical communication with the electro-active patency element. 
     
     
         86 . The device of  claim 86 , wherein the power supply comprises a battery. 
     
     
         87 . The device of  claim 86 , wherein the power supply comprises a capacitor. 
     
     
         88 . The device of  claim 80 , further comprising a battery in electrical communication with the implantable transducer. 
     
     
         89 . The device of  claim 80 , further comprising a mouthpiece in communication with the implantable transducer. 
     
     
         90 . The device of  claim 90 , wherein the mouthpiece comprises a dental retainer. 
     
     
         91 . The device of  claim 91 , wherein the dental retainer comprising a induction coil and a power source. 
     
     
         92 . The device of  claim 92 , wherein the power source is a disposable battery. 
     
     
         93 . The device of  claim 92 , wherein the power source is a rechargeable battery. 
     
     
         94 . The device of  claim 91 , wherein the dental retainer further comprising a pulsewidth-modulation circuit. 
     
     
         95 . The device of  claim 91 , wherein the dental retainer is custom fit for the individual biological subject. 
     
     
         96 . The device of  claim 90 , wherein the mouthpiece is in conductive electrical communication with the implantable transducer. 
     
     
         97 . The device of  claim 90 , wherein the mouthpiece is in inductive electrical communication with the implantable transducer. 
     
     
         98 . The device of  claim 80 , wherein the implantable transducer comprises an inductive receiver. 
     
     
         99 . The device of  claim 99 , wherein the inductive receiver comprises a coil. 
     
     
         100 . The device of  claim 80 , wherein the implantable transducer comprises a conductive receiver. 
     
     
         101 . The device of  claim 101 , wherein the conductive receiver comprises a dental filling. 
     
     
         102 . The device of  claim 101 , wherein the conductive receiver comprises a dental implant. 
     
     
         103 . The device of  claim 101 , wherein the conductive receiver implanted in the oral cavity. 
     
     
         104 . The device of  claim 101 , wherein the conductive receiver implanted in the head and neck region of the biological subject. 
     
     
         105 . The device of  claim 80 , further comprising a dermal patch in communication with the implantable transducer. 
     
     
         106 . The device of  claim 106 , wherein the dermal patch comprises a coil, circuit and power source. 
     
     
         107 . The device of  claim 107 , wherein the power source comprises a battery. 
     
     
         108 . The device of  claim 107 , wherein the dermal patch further comprises a pulsewidth-modulation circuit. 
     
     
         109 . The device of  claim 107 , wherein the coil is in inductive communication with the patency element. 
     
     
         110 . The device of  claim 107 , wherein the coil is in conductive communication with the patency element. 
     
     
         111 . A method for maintaining or creating airway patency in a biological subject, comprising:
 implanting in the biological subject a patency element that changes shape in response to an electrical stimulus and comprises an electroactive polymer; and   energizing the patency element.   
     
     
         112 . The method of  claim 112 , further comprising inserting a mouthpiece into the mouth of the biological subject. 
     
     
         113 . The method of  claim 112 , wherein energizing the patency element comprises placing the patency element in electrical communication with a power supply. 
     
     
         114 . The method of  claim 114 , wherein placing the patency element in electrical communication with a power supply comprises inserting a mouthpiece into the mouth of the biological subject. 
     
     
         115 . The method of  claim 114 , wherein the electrical communication between the patency element and the power supply comprises inductive communication. 
     
     
         116 . The method of  claim 114 , wherein the electrical communication between the patency element and the power supply comprises conductive communication. 
     
     
         117 . The method of  claim 112 , further comprising implanting a transducer in the biological subject. 
     
     
         118 . The method of  claim 118 , further comprising placing the transducer in electrical communication with the patency element. 
     
     
         119 . The method of  claim 118 , wherein energizing the patency element comprises placing the transducer in electrical communication with a power supply. 
     
     
         120 . The method of  claim 112 , further comprising implanting a power supply in the biological subject. 
     
     
         121 . The method of  claim 121 , further comprising charging the power supply. 
     
     
         122 . The method of  claim 122 , wherein charging the power supply comprises wearing a mouthpiece. 
     
     
         123 . The method of  claim 112 , wherein the patency element is implanted at least in-part in a soft palate of the biological subject. 
     
     
         124 . The method of  claim 112 , wherein the patency element is implanted at least in-part in an airway sidewall of the biological subject. 
     
     
         125 . The method of  claim 112 , wherein the patency element is implanted at least in-part in a uvula of the biological subject. 
     
     
         126 . The method of  claim 112 , wherein the patency element is implanted at least in-part in a pharynx wall of the biological subject. 
     
     
         127 . The method of  claim 112 , wherein the patency element is implanted at least in-part in a trachea wall of the biological subject. 
     
     
         128 . The method of  claim 112 , wherein the patency element is implanted at least in-part in a larynx wall of the biological subject. 
     
     
         129 . The method of  claim 112 , wherein the patency element is implanted at least in-part in a nasal passage wall of the biological subject. 
     
     
         130 . The method of  claim 112 , further comprising implanting a dental implant, wherein the dental implant is configured for electrical communication with the patency element. 
     
     
         131 . The method of  claim 112 , further comprising filling a dental cavity with conductive dental filling for electrical communication with the patency element. 
     
     
         132 . The method of  claim 132 , further comprising implanting a coil in the head and/or neck region of the biological subject. 
     
     
         133 . The method of  claim 133 , wherein the coil is an inductive coil. 
     
     
         134 . The method of  claim 112 , further comprises placement of a dermal patch for patency element activation. 
     
     
         135 . A system for maintaining airway patency in a biological subject comprising:
 an implantable patency element that changes shape in response to an electrical stimulus;   an implantable transducer;   an implantable lead wire connecting the patency element and the transducer;   a removable transducer; and   a removable power source configured to supply electrical power to the removable transducer,   wherein the implantable patency element comprises an electroactive polymer.