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EP-3089712-B1 - MANDIBULAR ADVANCEMENT DEVICE

EP3089712B1EP 3089712 B1EP3089712 B1EP 3089712B1EP-3089712-B1

Inventors

  • KUHNS, DAVID W.
  • KIM, SUNG
  • LIPTAK, LEONARD A.
  • SHEPPARD, Laura

Dates

Publication Date
20260513
Application Date
20141224

Claims (11)

  1. A mandibular advancement device (100) for a patient comprising: an upper splint (102) and a lower splint (104); wherein the upper splint (102) comprises at least one upper fin (114), wherein the upper fin is located at a distance UD from back of the upper splint; and the lower splint (104) comprises at least one lower fin (116), wherein the lower fin is located at a first distance LD from back of the lower splint; and the upper splint comprises an imprint of an upper dentition of the patient configured to fit onto the upper dentition, and the lower splint comprises an imprint of a lower dentition of the patient configured to fit onto the lower dentition, and the at least one upper fin is affixed to the upper splint buccal to the buccal surface of the maxillary teeth, and when the upper splint is fit onto the upper dentition the at least one upper fin protrudes downward below the occlusal plane; and the at least one lower fin is affixed to the lower splint buccal to the buccal surface of the mandibular teeth, and when the lower splint is fit onto the lower dentition the at least one lower fin protrudes upward above the occlusal plane; each splint independently comprises a flat surface along a plane of the splint away from the patient's 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 to provide a gap (502) between the upper fin (114) and the upper splint (102) based on the patient anatomy; each splint independently forms an arch with an empty centre (206); each splint and its respective fins comprise a single contiguous unit; wherein each distance UD and each distance LD is unchangeable; wherein each of the at least one upper fin (114) comprises a front surface (202) and each of the at least one lower fin (116) comprises a back surface (204), wherein when the upper (102) and lower (104) splints are worn by the patient and the mouth is closed or reasonably closed, the front surface (202) of the at least one upper fin (114) contacts the back surface (204) of the at least one lower fin (116) along a contact surface, thereby causing mandibular advancement of a lower jaw of the patient; and wherein each upper fin and each lower fin are of sufficient height such that 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 device of claim 1, wherein the empty centre (206) provides room for a patient's tongue when the device is in use.
  3. The device of claim 1 or 2, 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.
  4. The device of any one of claims 1 to 3, wherein when an individual wearing the device closes his or her mouth the upper splint (102) contacts the lower splint (104) along a plane, wherein the plane is the same as a patient's occlusal plane.
  5. The device of any one of claims 1 to 4, further comprising 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.
  6. The device of any one of claims 1 to 5, further comprising one or more retention arms.
  7. The device of any one of claims 1 to 6, wherein when the device is worn by a patient and the patient's mouth is closed, the bottom surface of the upper splint and the top surface of the lower splint contact each other along the curve of the device, or the arch of the mouth, and the upper and lower splint contact each other along the plane of the splint, and the opposing surfaces of the splint are designed such that the plane of the splint equals the occlusal plane.
  8. A method of manufacturing a mandibular advancement device as set forth in claim 1, the method comprising the steps of: obtaining electronic data on the shape of an individual's dentition; digitally designing a mandibular advancement device according to the obtained data, wherein the mandibular advancement device comprises an upper splint (102) and a lower splint (104); automatedly milling each of the upper and lower splints from a single polymeric block according to the digital design.
  9. The method of claim 8, wherein each of the upper splint (102) and lower (104) splint is designed digitally and milled as a single unit according to a digital design.
  10. The method of claims 8 or 9, wherein the shape of each upper fin (114) and each lower fin (116) is independently selected from a predesigned digital library of fins.
  11. The method of claim 8, further comprising including in the digital design one or two or more gaps (502) between: the at least one lower fin (116) and the lower splint (104), or the upper fin (114) and the upper splint, wherein the gaps (502) are between the patient's dentition and each of the lower splint (104) or upper splint (102), and optionally wherein the gaps (502) are digitally designed to be varied in size, wherein the varied-sized gaps (502) optimize the retention of the device on the patient's dentition.

Description

RELATED APPLICATIONS FJELD OF THE INVENTION The present invention is in the field of mandibular advancement devices. BACKGROUND OF THE DISCLOSURE Snoring and mild sleep apnea are generally thought to be the result of a reduced or partial constriction of the airway during sleep. This may be attributed to soft tissue sinking and applying pressure on the airway during sleep including the mandible dropping and moving backwards. Mandibular advancement devices are designed to move the mandible forward to relieve the force applied from soft tissue during sleep and assisting in opening the airway. Depending on the patient, the advancement of the mandible may vary based on the response of the patient. Optimizing the adjustment is referred to as titration. Many devices are on the market today that serve to advance the mandible. A dual arch device comprising fins and an adjustment screw block are represented by Somnomed's Somnodent (U.S. Patent No. 6,604,527), the Dynflex Dorsal Appliance, and Dr. Nordstrom's NorSnor II produced by Murdock Labs since the 1980's. Each device has an adjustable upper screw mechanism with block, which upon adjustment applies a force against a lower fin or bite block that then moves the mandible forward. The threaded screw system, requires that the user apply an Allen wrench to adjust the screw for titration. These devices are handmade and built up using polymethylmethacrylate (PMMA) and the corresponding monomer, methylmethacrylate. The device is cured in the dental lab and custom designed for each patient. Reproduction of the quality and accuracy of the device is subject to human skill. Alternatively, there are devices that make an adjustment by changing out straps of different lengths to titrate the mandible forward. Examples of these are the Silent Nite (U.S. Patent No. 5,365,945) produced by Glidewell, and the Narval (U.S. Patent No. 7,146,982) produced by Resmed. These devices offer a possibly lower profile than the screw adjustment devices and also connect the upper and lower arch together. United States Patent No. 6,604,527 discloses a mandibular advancement device wherein the upper jaw has fitted to it an upper plate and the upper plate is firmly received, and generally comprises a body component and two opposed flange components that are located to be lying in an area beside and close to the posterior teeth, and particularly the buccal side of the upper posterior teeth. PCT Publication No. WO 2013/102095 discloses oral appliances and methods of using oral appliances for treatment of sleep disorders and conditions. PCT Publication No. WO 2013/124452 discloses a method of virtually designing a reduced shape of at least one artificial tooth adapted to be inserted in a denture for a patient. PCT Publication No. WO 2009/140720 discloses an apparatus for the alleviation of sleep apnoea in which dentition engagement units or dental overlays are shaped to engage the maxillary and mandibular dentition of a subject. German Patent Publication No. 10 2004 007008 discloses a stop mechanism attached to jaws of a human patient to keep the airway open for prevention of snoring that has projecting interlocking stops attached to rails fitting over upper and lower rows of teeth. Korean Patent Publication No. 20130111848 discloses a mandible splint with respect to a maxillary that is provided to allow an operator to easily attach the device in an oral cavity of a patient in an examination room and to adjust the device according to symptom or recovery from the symptom of the patient. Several limitations exist with these existing sleep apnea devices. First, the manual, artisanal fabrication method used by these devices limits the ability to consistently and precisely transfer the prescription into the device design. This limitation results in the need for additional adjustments. Second, the manual artisanal fabrication method requires the layering of monomers, which can subject the patient to higher levels of residual monomers. Third, existing device designs feature multiple components, straps, and screws that decrease durability, reliability, and ease of use. Fourth, the materials used in the manual, artisanal fabrication method require the device to be of a certain size to effectively withstand the normal intraoral forces that the device is subjected to. This size limitation results in decreased patient comfort and patient compliance. Therefore a need exists to provide a mandibular advancement device that provides advancement of the lower jaw through a series of splints digitally designed and milled to provide accurate increments of advancement for easy titration of the mandible, without the need for an adjustment screw mechanism or adjustment straps. SUMMARY OF THE INVENTION The invention is set out in the appended set of claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates an embodiment of the disclosed mandibular advancement devices. FIG. IA shows a front view of the device as it is worn