Mandibular advancement device
Disclosed herein are mandibular advancement devices comprising an upper splint and a lower splint, where the upper splint comprises one or more upper fins, where each upper fin is located at a distance UD from back of the upper splint; the lower splints comprise one or more lower fins, where each lower fin is located at a distance LD from back of the lower splint; where the position of the upper and lower fins is unchangeable. Also disclosed are methods of reducing partial constriction of airway during sleep for a patient, the method comprising identifying a patient in need thereof; and administering to the patient the disclosed mandibular advancement device. Also disclosed are methods of manufacturing a mandibular advancement device, the method comprising obtaining measurements from a patient's dentition; digitally designing a mandibular advancement device; and milling the mandibular advancement device.
1. A method of manufacturing a set of at least two mandibular advancement devices, the method comprising the steps of:
obtaining electronic data on the shape of an individual's dentition;
digitally designing a set of at least two mandibular advancement devices according to the obtained data;
wherein the set of at least two mandibular advancement devices comprise:
a first mandibular advancement device and a second mandibular advancement device,
the first mandibular advancement device comprising a first upper splint and a first lower splint;
the first upper splint comprises one or more upper fins, wherein each upper fin is located at a first distance UD from back of the first upper splint;
the first lower splint comprises one or more lower fins, wherein each lower fin is located at a first distance LD from back of the first lower splint;
the second mandibular advancement device comprising a second upper splint and a second lower splint;
the second upper splint comprises one or more upper fins, wherein each upper fin is located at a second distance UD from back of the second upper splint;
the second lower splint comprises one or more lower fins, wherein each lower fin is located at a second distance LD from back of the second lower splint;
each upper and lower splint is independently arch-shaped;
each upper and lower splint independently comprises an imprint of the patient's dentition along a plane of the splint contacting the dentition;
each fin is “L” shaped, with the leg of the “L” connecting the fin to its respective splint protruding along the occlusal plane buccally, while the other leg of the “L” protruding perpendicular to the occlusal plane away from the patient's gingiva;
each splint and its respective fins comprise a single contiguous unit;
automatedly milling each of the splints from a single polymeric block according to the digital design;
wherein each distance UD and each distance LD is unchangeable;
wherein:
i) the first distance UD is different than the second distance UD;
ii) the first distance LD is different than the second distance LD; or
iii) both the first distance UD is different than the second distance UD and the first distance LD is different than the second distance LD;
wherein the sum of the first distance UD and the first distance LD is different than the sum of the second distance UD and the second distance LD by an increment of 0.5 mm in the range of 0.5 mm to 6.0 mm;
wherein each upper fin comprises a front surface and each lower fin comprises a back surface, wherein when the upper and lower splints are worn by the individual, the front surface of the upper fin contacts the back surface of the lower fin along a contact surface; and
wherein when the patient's mouth is opened during sleep, the contact between the front surface of the upper fin and the back surface of the lower fin is maintained.
2. The method of claim 1 , further comprising using a computer aided design (CAD) process for the digital design.
3. The method of claim 1 , wherein each of the first and second upper splint and lower splint independently comprises an empty center, wherein the empty center provides room for a patient's tongue when the device is in use.
4. The method of claim 1 , wherein a rake angle of the contact surface is selected from the group consisting of a neutral angle, a recline angle, and a procline angle.
5. The method of claim 1 , wherein the shape of each upper fin and each lower fin is independently selected from a predesigned digital library of fins.
6. The method of claim 1 , further comprising including a gap between the lower fin and the lower splint in the digital design.
7. The method of claim 1 , further comprising a gap between the upper fin and the upper splint in the digital design.
8. The method of claim 1 , further comprising in the digital design two or more gaps between the lower fin and each of the first and second lower splint, or further comprising two or more gaps between the upper fin and the first and second upper splint, wherein the gaps are between the patient's dentition and each of the lower splint or upper splint, and wherein the gaps are digitally designed to be varied in size, wherein the varied-sized gaps optimize the retention of the device on the patient's dentition.
9. The method of claim 1 , wherein one of the first or second upper splint is designed to contact one of the first or second lower splint along a plane, wherein the plane is the same as a patient's occlusal plane.
10. The method of claim 1 , wherein one of the first or second lower splint is designed to contact one of the first or second upper splint along a plane, wherein the plane is the same as a patient's occlusal plane.
11. The method of claim 1 , further comprising in the digital design one or more structural feature configured to accommodate an add on selected from the group consisting of a support member, a ball clasp, retention wire, treatment wire, alignment wires, and a tongue behavior modification wire.
12. The method of claim 1 , further comprising one or more retention arms in the digital design.