Abstract
A medical appliance for the treatment of obstructive sleep apnea in a patient, the appliance comprising: a securing device configured to be removably affixed to the patient's jaw; and a biasing member which is insertable behind the soft palate and/or the base of the patient's tongue, thereby providing for the flow of air in the nasopharyngeal airway; wherein the securing device is connected to the biasing member to allow insertion and/or removal of the biasing member from the nasopharyngeal airway.
Claims
1. (canceled)
2. A kit for selecting a medical appliance for a patient comprising: (a) two or more medical appliances, wherein each appliance comprises one or more unique parameters selected from the group consisting of: size; geometry; exerted force; and range of adjustability; and (b) a visualization apparatus comprising at least one device selected from the group consisting of: a camera; a camera lens; and a CCD assembly; wherein the visualization apparatus is used to select one of the two or more medical appliances for insertion into the patient, and wherein each of the medical appliances is constructed and arranged to apply a force to the soft palate and/or base of the tongue of the patient.
3. The kit according to claim 2, wherein a first of the two or more medical appliances comprises a first range of adjustability and a second of the two or more medical appliances comprises a second range of adjustability that is different from the first range.
4. The kit according to claim 2, wherein the visualization apparatus is configured to provide an image of an area behind the soft palate of the patient and/or an area behind the base of the tongue of the patient.
5. The kit according to claim 2, wherein the visualization apparatus is configured to visualize an amount of contact between each medical appliance and the soft palate and/or base of the tongue of the patient.
6. The kit according to claim 2, wherein the visualization apparatus is configured to quantify the size of an opening between each medical appliance and the soft palate and/or base of the tongue of the patient.
7. The kit according to claim 2, wherein the visualization apparatus further comprises a fiber optic cable.
8. The kit according to claim 2, wherein the visualization apparatus is electronically attached to a monitor.
9. The kit according to claim 2, wherein the visualization apparatus is inserted into the mouth or nose of the patient.
10. The kit according to claim 2, wherein the medical appliances are attachable to either the upper or lower jaw of the patient.
11. The kit according to claim 2, wherein each of the medical appliances treats obstructive sleep apnea in the patient.
12. The kit according to claim 2, wherein each of the medical appliances is inserted into the mouth of the patient.
13. The kit according to claim 2, wherein each of the medical appliances further comprises: a securing device configured to be removably affixed to the jaw of the patient; and a biasing member which is insertable behind the soft palate and/or the base of the tongue of the patient, thereby providing for the flow of air in the nasopharyngeal airway; wherein said securing device is connected to said biasing member to allow for the insertion and/or removal of said biasing member from the nasopharyngeal airway.
14. The kit according to claim 13, wherein the securing device comprises a palate retainer.
15. The kit according to claim 13, wherein the securing device is attachable to either the upper or lower jaw of the patient.
16. The kit according to claim 13, wherein the biasing member comprises at least one tube.
17. The kit according to claim 13, wherein the biasing member comprises at least one member selected from the group consisting of: a flexible or rigid stent; balloon; memory wire; and combination thereof.
18. The kit according to claim 13, wherein the nasopharyngeal airway comprises a nasopharynx region and/or an oropharynx region.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0048] FIG. 1 is a cross-sectional view of a patient's soft palate, oral cavity and pharynx without any appliance disposed therein;
[0049] FIG. 2 is a schematic representation of a palate retainer with a tube shaped nasopharyngeal extension having a ventilation hole disposed therein, and a nasopharyngeal visualization system inserted through a nostril of a patient, according the present disclosure;
[0050] FIG. 3 is a schematic representation of the tube shaped nasopharyngeal extension of FIG. 2, wherein the tube expansible in both the upper and lower directions;
[0051] FIG. 4 is a schematic representation of the palate retainer with a tube shaped nasopharyngeal extension disposed behind the soft palate, wherein the palate retainer is secured to the teeth in the upper jaw to hold it in place;
[0052] FIG. 5 is a schematic representation of the palate retainer of FIG. 4, wherein the tube shaped nasopharyngeal extension is expanded in both the upper and lower directions;
[0053] FIG. 6 is a front perspective view of a palate retainer with a perforated tube shaped nasopharyngeal extension, wherein the retainer has a retainer portion which is configured to come into contact with the soft palate of a patient;
[0054] FIG. 6a is a front perspective view of a palate retainer with a solid tube shaped nasopharyngeal extension, wherein the retainer has a retainer portion which is configured to come into contact with the soft palate of a patient;
[0055] FIG. 7 is a front perspective view of a palate retainer with a tube shaped nasopharyngeal extension, wherein the retainer has a retainer portion which is configured to be affixed to the upper jaw, but not come in contact with a substantial portion of the soft palate of a patient, wherein the tube shaped nasopharyngeal extension is secured to the retainer portion by means of a pair of curved ribbons, strap, conduits, etc.;
[0056] FIG. 7a is a front perspective view of a palate retainer with a tube shaped nasopharyngeal extension, wherein the retainer has a retainer portion which is configured to be affixed to the upper jaw, but not come in contact with a substantial portion of the soft palate of a patient, wherein the tube shaped nasopharyngeal extension is secured to the retainer portion by means of a single curved ribbon, strap, conduit, etc.;
[0057] FIG. 7b(i) is yet another embodiment of the present disclosure depicting a palate retainer, wherein the retainer has a retainer portion which is configured to be affixed to the upper jaw, but not come in contact with a substantial portion of the soft palate of a patient, and wherein a stent housing in the general shape of a curved or “C” shaped tube or ribbon for housing an expandable stent therein is disposed about at least one portion of the retainer portion;
[0058] FIG. 7b(ii) depicts the stent of FIG. 7b(i) wherein the stent is in the exposed or expanded position, where, when attached to the upper jaw, the stent would expand upwards behind the soft palate from the tip of the curved hollow ribbon or tube;
[0059] FIGS. 7b(iii)(a)-(d) are various embodiments wherein the stent of FIG. 7b(i) is replaced with inflatable balloons or expandable wire balls;
[0060] FIG. 7b(iv) is another embodiment wherein the stent of FIG. 7b(i) is replaced with a memory wire which forms a spiral or helical configuration when exposed;
[0061] FIG. 7b(v) is another embodiment wherein the stent of FIG. 7b(i) is replaced with a memory wire which forms a loop or elliptical configuration when exposed;
[0062] FIG. 7c(i) is yet another embodiment of the present disclosure depicting a the stent of FIG. 7b(i) wherein the stent is formed of metal or magnetic wire mesh and wherein at least one magnet is disposed about the retainer portion (preferably after the metal or magnetic wire mesh is expanded from the hollow stent housing behind the soft palate), thereby allowing for the soft palate to be held in an opened position due to the magnetic force between the magnet on the retainer portion and the wire mesh expanded behind the soft palate;
[0063] FIG. 7c(ii) depicts the stent of FIG. 7c(i) wherein the stent is in the exposed or expanded position;
[0064] FIG. 7d is a cross-sectional view of an appliance according to the present disclosure according to another embodiment, wherein a palate retainer is a platform for both a fixed tube behind the soft palate and a downwardly expandable tube behind the base of a tongue, optionally, with an expansion bulb or the like;
[0065] FIG. 8 is a schematic representation of a side view of an appliance according the present disclosure, wherein an adjustable palate retainer is attached to adjustable upper and lower extensions, optionally with a force transducer in communication with an electronic assembly, consistent with the present invention;
[0066] FIG. 9 is a front perspective view of an appliance according to the present disclosure, wherein a palate retainer is removably attachable to a collar portion which is attached to a tube shaped nasopharyngeal extension, wherein the retainer includes two pivotally attached portions and an electronic module in electronic communication with strain gauges integral to the nasopharyngeal extension;
[0067] FIG. 10A a schematic representation of a side view of an appliance according to the present disclosure, wherein an upper extension is rotatably attached to the palate retainer, maintained in a pre-deployed position by a band;
[0068] FIG. 10B is a schematic representation of the side view of the appliance of FIG. 10A wherein the band has been removed and the upper extension has rotated into a deployed position;
[0069] FIG. 11 is a flow chart of a preferred method of diagnosing a patient suspected of having sleep apnea using an appliance of the present disclosure; and
[0070] FIG. 12 is a flow chart of a preferred method of manufacturing an appliance of the present disclosure.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0071] The present disclosure can best be described by referring to the figures, wherein FIG. 1 shows a cross-section of a patient's oral cavity 1. Oral cavity 1 includes a tongue 3, upper jaw 5, lower jaw 7, soft palate 9, and epiglottis 11, as well as the nasopharynx region 13, oropharynx region 15 and laryngopharynx region 17.
[0072] FIG. 2 depicts system 200 which comprises visualization apparatus 180 and appliance 100. Appliance 100 includes palate retainer 20 and a tube shaped nasopharyngeal extension 24. Palate retainer 20 has been positioned about the upper jaw 5 and secured thereto via a wire or other removable securing device 22, such as a wire connected to the teeth. Affixed to retainer 20 by a neck or collar portion 21 is tube shaped nasopharyngeal extension 24 which can be a solid tube with an air passageway disposed thereto to allow air to flow from the nasal passageway 26 through nasopharynx region 13 and into the oropharynx region 15 and laryngopharynx region 17. Collar portion 21 may be configured to flex, such as via an integral hinge or flexible joint, to avoid applying excessive force to tissue such as when the patient swallows. Alternatively, tube shaped nasopharyngeal extension 24 can be formed of a wire mesh or other material which is capable of permitting air to flow therethrough, while splinting soft palate 9 and tongue 3, thereby preventing soft palate 9 and tongue 3 from falling back while at the same time providing a rigid air passageway in the retopalatal and retrolingual space that cannot collapse. Extension 24 may include one or more expanding members, such as an expandable cage or balloon, configured to apply a force to maintain patience of an airway of the patient. System 200 further includes visualization apparatus 180 comprising monitor 181 which is electronically attached to camera 182. Camera 182 attaches to fiberscope 185 at jack 183. The distal end of fiberscope 185 includes lens 186, typically a fish eye or other end or side view lens configured to provide an image of the air passageways and/or inserted devices, such as an endoscopic camera commonly used in various medical procedures. Visualization apparatus 180 can be used to diagnose or prognose a patient's sleep apnea, such as when an appliance of the present invention is inserted behind the soft palate and/or the base of the patient's tongue. Alternatively or additionally, visualization apparatus 180 can be used to adjust one or more parameters of an appliance of the present invention, such as adjusting the size, geometry, exerted force, or other adjustable parameter of the appliance, described in detail herebelow. Alternatively or additionally, visualization apparatus 180 can be used to select from two or more differently configured appliances of the present invention, such as to select an appliance of appropriate geometry for a specific patient, to provide enhanced therapeutic benefit to that patient. In a system of the present invention, one appliance may have a first range of adjustability, and a second appliance may have a second range of adjustability different than the first.
[0073] FIG. 3 demonstrates an alternative embodiment of the present disclosure wherein tube shaped nasopharyngeal extension 24 may include either an upper (superior) extension 30 or lower (inferior) extension 32. Such extensions 30, 32 can be gravity or spring actuated, and formed of materials which allow for collapsing or bending, and for easy removal from oral cavity 1 after use. Preferably, upper extension 30 is formed of a perforated material, such as wire mesh with, optionally, reinforced sections to prevent collapse, to all for air to flow therethrough. Alternatively, extension 30 can also be formed of a solid material, similar or identical to that of nasopharyngeal extension 24. Although, lower extension 32 is preferably formed of a solid material, it can also be formed of a perforated material similar to upper extension 30. Upper and lower extensions 30 and 32 have a construction including one or more air flow channels, or are made of porous or perforated materials that allow air to pass through. Having upper and lower extension (30, 32) protruding from nasopharyngeal extension 24 provides for reinforcement of the soft palate and tongue over a greater distance or length, and thereby prevents constriction between soft palate 9 and nasopharynx region 13 and/or between tongue 3 and oropharynx region 15 due to sleep apnea conditions.
[0074] FIG. 4 is a schematic representation of a front planar view of oral cavity 1, wherein the upper jaw 5 and lower jaw 7 are spread apart to show tongue 3, as well as the preferred positioning of palate retainer 20 about the palate 40, such that tube shaped nasopharyngeal extension 24 is disposed behind soft palate 9. FIG. 4 also shows wire or securing device 22 affixed to opposite sides of upper jaw 5 via securing wire 22 about a respective tooth 42a and 42b on each side thereof. Securing wire 22 holds palate retainer 20 in place about palate 40 such that nasopharyngeal extension 24 is securely positioned behind soft palate 9 by means of a molded collar or neck 21 disposed between retainer 20 and extension 24 to maintain an air passageway between soft palate 9 and nasopharynx region 13 and oropharynx region 13 during sleep apnea attacks. Neck 21 may be configured to flex, such as via an integral hinge or flexible joint, to avoid applying excessive force to tissue such as when the patient swallows. 21
[0075] FIG. 5 is similar to FIG. 4, but demonstrates nasopharyngeal extension 24 with upper and lower extensions 30 and 32, as shown in FIG. 3. This configuration is capable of permitting air to flow therethrough, while splinting soft palate 9 and tongue 3, thereby preventing soft palate 9 and tongue 3 from falling back while at the same time providing a rigid air passageway in the retopalatal and retrolingual space that cannot collapse.
[0076] FIGS. 6 and 6a depict palate retainer 20 having a perforated and solid tube shaped nasopharyngeal extensions 50 and 52, respectively, connected thereto by support 54 which resides in front and below the soft palate. In this embodiment, retainer 20 includes a continuous retainer portion 56 which is disposed about the palate of the upper jaw, not shown. Extension 50 of FIG. 6 has a porous or perforated construction, while extension 50 of FIG. 6a has a solid tube construction.
[0077] FIG. 7 is another embodiment according to the present disclosure, wherein a non-continuous retainer portion 58 is used in order to avoid substantial contact between the palate of the upper jaw and retainer portion 58, as well as the soft palate to avoid irritation or gagging due to such contact. Retainer portion 58 is secured to nasopharyngeal extension 60 via a pair of oppositely disposed arched or “C” shaped necks or collars or ribbons 62, 64 or other securing devices which bend around the sides of the soft palate to hold tube 60 behind the soft palate. Ribbons 62 and/or 64 may be configured to allow flexing between retainer 20 and extension 60, such as during swallowing.
[0078] FIG. 7a is a front perspective view of palate retainer 20 with tube shaped nasopharyngeal extension 60, wherein retainer 20 has a retainer portion 58 which is configured to be affixed to the upper jaw, but not come in contact with a substantial portion of the soft palate of a patient, wherein tube shaped nasopharyngeal extension 60 is secured to the retainer portion by means of a single curved ribbon, strap, conduit, neck, collar, etc. 61, preferably configured to flex during swallowing.
[0079] FIGS. 7b(i) and (ii) is yet another embodiment of the present disclosure depicting palate retainer 20, wherein retainer 20 has retainer portion 58 which is configured to be affixed to the upper jaw (not shown), but not come in contact with a substantial portion of the soft palate of a patient, and wherein a stent housing 71 in the general shape of a tube or ribbon for housing expandable stent 73 therein is disposed about at least one portion of retainer portion 58. FIG. 7b(ii) depicts stent 73 in the exposed or expanded position. In an alternative embodiment, a second stent housing 71 is included, not shown but preferably in a mirrored or symmetric configuration, on the opposite side of palate retainer 20, and configured to exert a force on the opposite side of the soft palate of the patient.
[0080] Alternatively, the stent of FIG. 7b(i) can be replaced with the balloons of FIGS. 7b(iii)(a)-(d), wherein (a) and (b) show a pair of balloons 201 or expandable wire balls that can be either inflated or expanded by mechanical means, not shown. FIG. 7(b)(iii)(c) depicts a pair of inflatable disks 203 encased in a wire mesh 205 according to still yet another embodiment of the present disclosure. FIG. 7(b)(iii)(d) is yet another embodiment wherein inflatable units 207 are encased in a wire mesh 209.
[0081] FIG. 7b(iv) is another embodiment wherein the stent of FIG. 7b(i) is replaced with a memory wire 211 which forms a spiral or helical configuration when exposed, such as when mechanically released or when exposed to body temperature. Memory wire 211 may comprise a resiliently biased material, such as Nitinol wire in a superelastic state or other elastic metal, alloy or plastic. Alternatively, memory wire 211 may comprise a shaped-memory material, such as a shaped memory alloy or shaped memory polymer.
[0082] FIG. 7b(v) is another embodiment wherein the stent of FIG. 7b(i) is replaced with a memory wire 213, constructed of one or more materials described in reference to memory wire 211 of FIG. 7b(iv). Memory wire 213 forms a loop or elliptical configuration when exposed, such as when mechanically released or when exposed to body temperature.
[0083] FIGS. 7c(i) and (ii) is yet another embodiment of the present disclosure depicting stent housing 71 comprising stent 73 which is preferably formed of a metal or magnetic wire mesh, and wherein at least one magnet 75, comprising a corresponding magnet or magnetic material, is disposed about retainer portion 58, thereby allowing for the soft palate (not shown) to be held in an opened position due to the magnetic force between magnet 75 and the wire mesh stent 73 disposed in the expanded position behind the soft palate. In an alternative embodiment, a second stent housing 71 is included, not shown but preferably in a mirrored or symmetric configuration, on the opposite side of palate retainer 20, and configured to exert a force on the opposite side of the soft palate of the patient. In another alternative embodiment, stent housing 71 may be a simple wire or ribbon, without an internal stent, configured to exert a force on the soft palate. The wire or ribbon may include one or more magnets or magnetic materials that exert a force on the soft palate caused by their attraction force toward a corresponding magnet or magnetic material disposed about retainer 20, disposed in a separate component of the appliance, and/or implanted in the patient. The wire or ribbon may include one or more expandable assemblies, such as one or more expandable balloons configured to exert a force on the soft palate.
[0084] Alternatively or additionally, magnets or metal wire can be implanted within the soft palate, thereby utilizing magnetic forces to move the soft palate toward magnet 75 to keep the soft palate from collapsing into the airway of the patient.
[0085] FIG. 7d is yet another embodiment according to the present disclosure and depicts a cross-sectional view of an appliance 77, wherein palate retainer 20 is a platform for both a fixed tube 24 disposed behind soft palate 9 and a downwardly expandable tube 79 disposed behind the base of a tongue 3, optionally, with a expansion bulb or the like (not shown but preferably an expandable balloon or an expandable cage). In an alternative embodiment, tube 79 is of ribbon or wire construction, such as a nitinol ribbon or other elastically biased ribbon or wire configured to apply pressure behind the tongue of the patient. Fixed tube 24 and expandable tube 79 may be attached to retainer 20 such as to allow movement such as during patient swallowing.
[0086] Optionally, the nasopharyngeal extensions are formed of a compressed flexible tube with several hard plastic rings to prevent collapse of the tube.
[0087] FIG. 8 demonstrates an alternative embodiment of the appliance of the present disclosure wherein appliance 100′ includes adjustable palate retainer 120 which attaches to a palate extender device, adjustable upper extension 130. Upper extension 130 is adjustably attached to a base of tongue extender device, lower extension 140, which is also adjustable. Palate retainer 120 includes securing element 122, preferably two wire filaments, one on each side of the upper jaw, configured to be removably attached to the patient's upper teeth. Alternatively or additionally, appliance 100′ and the other appliances of the present invention may be attached to the teeth of the lower jaw of the patient. Palate retainer 120 further includes proximal portion 120a and distal portion 120b which are adjustably attached via horizontal adjustment means 123, such as a rack and pinion or other mechanical adjustment assembly. Adjustment means 123 can be adjusted, such as via a screwdriver or other tool, to adjust the overall length of palate retainer 120. Palate retainer 120 includes, on its distal end, collar portion 121 which flexibly and adjustably attaches to upper extension 130 via vertical adjustment means 124. Vertical adjustment means includes rack 125 such that rotation of a screw of vertical adjustment means 124 causes vertical translation (e.g. rack and pinion superior and inferior adjustment) of upper extension 130 relative to palate retainer 120.
[0088] Upper extension 130 attaches to lower extension 140 via a vertically adjustable assembly comprising upper arms 126a and 126b which adjustably attach to lower arms 128a and 128b respectively. Adjustment means 127a adjustably connects upper arm 126a to lower arm 128a. Adjustment means 127b adjustably connects upper arm 126b to lower arm 128b. Adjustment means 127a and 127b each include a rotating screw or other means configured to move lower extension 140 toward or away from upper extension 130.
[0089] Upper extension 130 may include means of adjusting its outer diameter, diameter adjustment means 132, such as a screwdriver or other tool activated mechanism which causes radial expansion or contraction of upper extension 130. Adjustment can be performed prior to, during, or after placement of upper extension 130 behind the patient's soft palette. In a preferred embodiment, upper extension 130 is a wound coil, and activation of adjustment means 132 causes edge 131 to rotationally translate to increase or decrease the relative diameter of upper extension 130. Lower extension 140 may include means of adjusting its outer diameter, diameter adjustment means 142, of similar or dissimilar configuration to adjustment means 132 of upper extension 130, but preferably configured to be operably adjusted by a screwdriver or other tool to radially expand or contract lower extension 140, such as by translation of edge 141. Similarly, lower extension 140 may be adjusted prior to, during, or after placement behind the base of the tongue of the patient. In an alternative embodiment, upper extension 130 and/or lower extension 140 include one or more heat-activated components, such as one or more Nitinol components configured to expand at body temperature, such that radial expansion occurs as upper extension 130 and/or lower extension 140 transition from room temperature to body temperature (e.g. soon after placement in the patient's mouth).
[0090] Upper extension 130 may further include a sensor assembly, such as strain gauge assembly 160, configured to provide information regarding one or more patient conditions or one or more conditions of upper extension 130. Strain gauge assembly 160 attaches to electronic module 150 of palate retainer 120 via wire 161, typically a bundle of wires and/or optical fibers which attaches to wire 151, also typically a bundle of wires and/or optical fibers. Wire 151 is connected to electronic module 150. Electronic module 150 may include power, such as battery power, and signal storage and/or processing means, such as means to store and/or process the information received from strain gauge assembly 160. This information can be used to diagnose or prognose a patient's sleep apnea condition (e.g. the amount of force being applied to upper extension 130, such as during sleep where higher closing force may correspond to more severe sleep apnea), and or optimize the adjustable parameters of one or more components of appliance 100′ (e.g. upper extension 130 diameter and/or vertical positioning). Electronic module 150 may include an electronic attachment port, jack 152, which allows attachment of a handheld or other electronic device which can download or upload information from or to electronic module 150. Alternatively or additionally, lower extension 140 may include a strain gauge assembly, not shown but preferably electrically connected to electronic module 150 or another electronic assembly.
[0091] Upper Extension 130 may further include a visualization element, lens assembly 170, a camera or camera lens assembly. Lens assembly 170 attaches to electronic module 150 of palate retainer 120 via wire 171, typically a bundle of wires and/or optical fibers which is attached to wire 151, also typically a bundle of wires and/or optical fibers attached to electronic module 150. Lens assembly 170 provides an image of the inner surface of upper extension 130 and the tissue surrounding upper extension 130 (e.g. the soft palate), and can be used to diagnose or prognose the patient's sleep apnea condition as well as adjust one or more parameters of appliance 100′ such as the diameter of upper extension 130. Lens assembly 170 may be a CCD device used to record images, or may be a lens assembly in optical communication with a separate CCD device such as a CCD device integral to electronic module 150 or connected to electronic module 150 via jack 152. Alternatively or additionally, lower extension 140 may include a camera or lens assembly, not shown but preferably electrically connected to electronic module 150 or another electronic assembly.
[0092] FIG. 9 demonstrates an alternative embodiment of the appliance of the present disclosure wherein appliance 100″ includes a hinged palate retainer 120 which attaches to a palate extender device, upper extension 130 via a detachable collar portion 121, which is configured to reside in front and below (inferior to) the soft palate and flex such that upper extension 130 can flex in relation to retainer 120. Palate retainer is configured for attachment to the teeth of the upper jaw, via securing elements 122, as has been described hereabove. Palate retainer 120 includes receiving holes 134a and 134b which slidingly receive projecting pins 133a and 133b respectively, of collar portion 121, such that palate retainer 120 can be attached to collar portion 121 after upper extension 130 is in place behind the patient's soft palate. In an alternative embodiment, appliance 100″ may include multiple assemblies including collar portion 121 and upper extension 130, each configured to attach to a single palate retainer 120. Multiple sets of upper extension 130 and collar portion 121 may be useful in diagnosing and/or treating a patient's sleep apnea, such as when each set is of different construction (e.g. diameters, biasing forces, and other geometric and physical properties).
[0093] Palate retainer 120 includes two halved portions 120a and 120b which are rotatably connected via hinges 129a and 129b. such that palate retainer 120 can be folded when collar portion 121 is not attached. Palate retainer 120 further includes electronic module 150 which is electrically connected to wire 151, typically one or more wires and/or fiber optic cables. Wire 151 attaches to strain gauges 160a and 160b of upper extension 130. Forces recorded by strain gauges 160a and 160b are received and preferably recorded by electronic module 150, as has been described above in reference to FIG. 8, to diagnose, prognose, and/or modify treatment of a patient having or suspected of having sleep apnea.
[0094] FIGS. 10A and 10B demonstrate an alternative embodiment of the appliance of the present disclosure wherein appliance 100′ includes an adjustable length palate retainer 120 which is rotatably attached to upper extension 130. Palate retainer 120 includes securing elements 122 (one shown in side view but preferably one on each side) which attach palate retainer 120 to the teeth of the patient's upper jaw. Palate retainer 120 includes, on its distal end, collar 121, which is configured to reside in front and below (inferior to) the soft palate of the patient. Collar 121 attaches to a palate extender device, upper extension 130 via spring loaded hinge 135.
[0095] Referring specifically to FIG. 10A, upper extension 130 is biased in a pre-deployed position by band 136 preferably of a rubber band or similar elastically biased construction connected the bottom portion of upper extension 130 to one or more securing elements 122, such as via one or more hooks on upper extension 130 and/or securing elements 122, that engage looped ends of band 136, hooks and loops not shown. In an alternative embodiment, a gentle detachment or tearing force is applied to remove band 136 from securing element 122 and/or upper extension 130. In the configuration of FIG. 10A, appliance 100′ can be easily inserted into the patient's mouth, and securing elements 122 attached to the teeth of the patient's upper jaw.
[0096] Once in place, band 136 can be detached from either or both securing element 122 and upper extension 130, allowing upper extension 130 to rotate to a position applying a biasing force to the patient's soft palate, in the configuration of FIG. 10A, patient's anatomy not shown but described in detail hereabove. In a preferred method, band 136 is removed from securing element 122 first, and slow manual translation of the band toward the back of the patient's throat causes a slow deployment of upper extension 130 to be located behind and apply a force to the soft palate of the patient. Once in place, band 136 can be removed from upper extension 130 as has been described above.
[0097] FIG. 11 demonstrates a preferred method of diagnosing a patient known to have or suspected of having sleep apnea. In Step 200, an appliance or system of the present invention is selected. The appliance selected may include one or more diagnostic or sensing capabilities such as the force measurement capabilities of an appliance of the present invention, such as the appliances 100′ or 100″ of FIG. 8 or 9, respectively. The appliance selected may be a system of the present invention, such as system including two or more different appliances, or a system including a visualization instrument, such as system 200 of FIG. 2, and an appliance of the present invention.
[0098] In Step 201, the appliance is inserted into the patient's mouth, and a extender device of the appliance is placed behind the soft palate and/or behind the base of the patient's tongue. At this time, one or more other devices may be inserted into the patient, such as visualization instrument 180 of FIG. 2, or put in a position to monitor one or more parameters of the patient, such as EEG or EKG electrodes, respiration monitors, snoring monitors, sound monitors, and other physiologic measuring sensors and/or devices used to diagnose, prognose or otherwise assess a sleep apnea patient.
[0099] In Step 202, the patient's breathing is assessed, such as by using the one or more diagnostic instruments described in reference to Step 201 above. In a preferred embodiment, the assessment includes a period of time when the patient is asleep. The assessment may include comparison to similar testing performed without an appliance of the present invention in place in the patient, or with a differently configured appliance used. The assessment phase may include adjusting one or more parameters of the appliance, such as to modify the magnitude of a biasing force applied to the soft palate and/or the base of the tongue. The assessment may include a comfort assessment, such as comfort assessed through measurement of physiologic parameters or by completing a patient questionnaire.
[0100] FIG. 12 demonstrates a preferred method of manufacturing or adjusting an appliance of the present invention for a particular patient known to have or suspected of having sleep apnea. In Step 300, a patient assessment is performed such as a diagnostic procedure performed while the patient is sleeping. The assessment may include the creation of one or more images used to determine the proper dimensions of the appliance, such as images created with technologies such as x-ray, CT scan, MM, ultrasound, and other imaging technologies commonly found in health care centers. The imaging may be created by a camera, such as a camera inserted to the areas behind the patient's soft palate and tongue (e.g. imaging scopes entered through the nose and/or the mouth), wherein visible light pictures are used to measure the patient's anatomy.
[0101] Step 301 includes the manufacture or adjustment of an appliance of the present invention based on the patient measurements performed and/or other data collected in Step 300. This manufacture of a new appliance, and/or adjustment of an existing appliance, allows patient-specific treatment of a particular patient's sleep apnea and yields improved comfort for the patient (with an inserted device), as well as better efficacy in treatment. Patient specific sizing of the extender devices (soft palate and/or base of tongue force exerting members) can be customized to apply a sufficient force to maintain proper airflow, without applying unnecessary force. Extender device geometry can be chosen to apply force where beneficial, and avoid tissue contact that is unnecessary. Non-circular profiles, such as crescent profiles, can be used for extender devices to avoid contact with tissue to which no force application is desired. This avoidance of skin contact can be particular important on the certain surfaces of the airways, such as some anterior airway surfaces, on which swallowing and gag reflexes are most sensitive.
[0102] While we have shown and described several embodiments in accordance with our invention, it is to be clearly understood that the same may be susceptible to numerous changes apparent to one skilled in the art. Therefore, we do not wish to be limited to the details shown and described but intend to show all changes and modifications that come within the scope of the appended claims. In addition, each of the drawings are not to scale, but are simply representative drawings to assist in the understanding of the present disclosure.
