Devices and methods for sleep apnea and snoring
A Mandibular Advancement Device (MAD) is disclosed which is useful for the treatment of snoring and Obstructive Sleep Apnea (OSA). The improved MAD design comprises upper and lower splints which can be set at an advanced protrusive position (as desired for snoring/OSA therapy), but which also permits some degree of lateral mandibular movement. The amount of protrusive mandibular advancement is adjustable.
1 . A device for adjusting mandibular position comprising:
an upper splint configured to receive at least some of a patient's upper teeth;
a lower splint configured to receive at least some of the patient's lower teeth;
an upper interface attached to said upper splint, said upper interface comprising at least one rail; and
a lower interface attached to said lower splint, said lower interface comprising at least one groove, wherein one of said at least one grooves is adapted to interface with one of said at least one rails by insertion of a front end of said rail into said groove to form at least one rail and groove connection that is adapted such that said rail may slide along said groove in a horizontal direction to alter positioning of said upper and lower splints relative to each other in said horizontal direction to project said lower splint forward in said horizontal direction relative to said upper splint, said rail being longer than said groove and comprising a stop formed on a rear end of said rail that is enlarged to prevent further sliding of said rail in said groove past said stop;
wherein said rail and said groove are shaped to prevent substantial vertical separation of said upper and lower splints after insertion of said rail into said groove.
2 . The device of claim 1 , wherein said at least one rail and groove connections further comprises two of said rails and two of said grooves.
3 . The device of claim 2 , wherein said at least one rail and groove connection comprises a left and right set.
4 . The device of claim 3 , wherein said left and right sets are connected to said upper and lower splints at left and right sides of an arcuate portion of said upper and lower splints.
5 . The device of claim 1 , further comprising at least one spacer adapted to adjust said positioning by extending said stop on said rail.
6 . The device of claim 5 , wherein said at least one spacer comprises a feature for locking in said spacer on said rail.
7 . The device of claim 6 , wherein said feature for locking in said spacer comprises a snap-in interface.
8 . The device of claim 1 , wherein said at least one rail and groove connections comprises lateral space between said rail and groove from at least a portion of said rail being smaller than a corresponding portion of said groove and formed to allow said rail and groove to move laterally and vertically relative to each other when interfaced.
9 . The device of claim 1 , wherein said upper and lower splints are configured to rest in a non-parallel orientation relative to each other when said upper and lower interfaces interconnect.
10 . The device of claim 1 , wherein said rail comprises a dovetail-shaped rail and said groove comprises a corresponding-shaped groove.
11 . The device of claim 1 , wherein said device is constructed from a material selected from the group consisting of acrylic, polycarbonate (PC), polyurethane, polyethylene (PE), polypropylene (PP), polylactic acid (PLA), silicone, nylon, polyvinylchloride (PVC), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), acrylonitrile butadiene styrene (ABS), polyether sulphone (PES), polyetheretherketone (PEEK), fluorinated ethylene propylene (FEP), and combinations thereof.
12 . The device of claim 1 , wherein said rail is attached to said upper splint and said groove is attached to said lower splint by adhesive.
13 . The device of claim 1 , wherein said groove is open on a front end and a back end.
14 . The device of claim 1 , wherein said rail comprises a single-sided dovetail-shaped rail and said groove comprises a corresponding-shaped groove.
15 . A method for customizing a device for adjusting mandibular position comprising:
providing an upper and lower splint configured to receive at least some of a patient's upper and lower teeth, respectively;
attaching a first and a second rail to said upper splint and attaching a first and a second groove to said lower splint such that said lower splint is configured to be biased forward in said patient's mouth relative to said upper splint when said first and second rails are inserted into said first and second grooves to form a first and a second rail and groove connection, respectively, said rails being longer than said grooves and adapted such that said first and second rails may slide along said first and second grooves, respectively, to alter horizontal positioning of said upper and lower splints relative to each other that are shaped to retain each other in connection and said rails each comprising a stop formed on a rear end of each of said rails that is enlarged to prevent further sliding of said rails in the respective said grooves past said stop; and
utilizing a mounting device to retain and adjust the position of said rail and groove connections relative to said upper and lower splints to adjust the fit and positioning of said upper and lower splints relative to each other for use by said patient, said mounting device comprising two substantially identical portions that interconnect with each other via corresponding male and female connection portions and each having apertures shaped for retaining one of said rail and groove connections, wherein said mounting device is wholly separate and removable from said upper and lower splints and said rail and groove connections after said positioning.
16 . The method of claim 15 , further comprising adjusting said fit and positioning of said upper and lower splints relative to each other for use by said patient by addition of at least one spacer.
17 . The method of claim 15 , wherein said mounting device adjusts laterally to accommodate differing widths of jaws and arcuate portions of said upper and lower splints.
18 . The method of claim 15 , further comprising adhering said rails and grooves to said upper and lower splints and removing said mounting device after said adhering.
19 . The device of claim 15 , wherein said rails and grooves are adhered to said upper and lower splints in a configuration to enable sliding of said rails and grooves relative to each other in an approximately horizontal direction.
20 . The method of claim 15 , wherein rails and grooves are adhered in a configuration such that said upper and lower splints rest in a non-parallel orientation relative to each when said rails and grooves interconnect.