IP Library › Granted Patent US 12,186,232
Granted Patent B2
US 12,186,232 · App. 18/387,227 · Granted Jan 7, 2025

Mandibular advancement device

Inventors: Sung Kim (Pleasanton, CA); Leonard A. Liptak (Pleasanton, CA); David W. Kuhns (Pleasanton, CA)
Assignee: ProSomnus Sleep Technologies, Inc.
A61F5/566A61C7/08A61C7/36B23C3/00B23C2226/61
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Quick Facts
Patent No.
US 12,186,232
App. No.
18/387,227
Filed
Nov 6, 2023
Granted
Jan 7, 2025
Kind
B2
Art Unit
3786
USPC
409/131
Abstract

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.

Claims (37)

1. A set of splints for repositioning a mandible of a patient, comprising:

a first splint configured to fit onto a dentition of the patient, the first splint comprising an imprint of the dentition configured to fit onto the dentition;

a first fin coupled to the first splint to be located at a first distance from a back of the first splint;

a second splint configured to fit onto the dentition, the second splint comprising the imprint of the dentition configured to fit onto the dentition;

a second fin coupled to the second splint to be located at a second distance from a back of the second splint, wherein the first distance is different from the second distance;

an opposing splint configured to fit onto an opposing dentition of the patient to oppose the first or second splint when the first or second splint fits onto the dentition, the opposing splint comprising an imprint of the opposing dentition configured to fit onto the opposing dentition; and

an opposing fin coupled to the opposing splint and configured to:

contact the first fin to reposition the mandible based on the first distance when the first splint fits onto the dentition and the opposing splint fits onto the opposing dentition to oppose the first splint, and

contact the second fin to reposition the mandible based on the second distance when the second splint fits onto the dentition and the opposing splint fits onto the opposing dentition to oppose the second splint.

2. The set of splints of claim 1 , wherein

the first fin comprises a first left fin and a first right fin, wherein the first right fin has the same first distance from the back of the first splint as the first left fin,

the second fin comprises a second left fin and a second right fin, wherein the second right fin has the same second distance from the back of the second splint as the second left fin, or

the opposing fin comprises an opposing left fin and an opposing right fin, wherein the opposing right fin has the same distance from a back of the opposing splint as the opposing left fin.

3. The set of splints of claim 1 , wherein the first and second splints are upper splints configured to fit onto the dentition being an upper dentition, and the opposing splint is a lower splint configured to fit onto the opposing dentition being a lower dentition.

4. The set of splints of claim 1 , wherein the first and second splints are lower splints configured to fit onto the dentition being a lower dentition, and the opposing splint is an upper splint configured to fit onto the opposing dentition being an upper dentition.

5. The set of splints of claim 1 , wherein the opposing fin is configured to contact the first fin to reposition the mandible as a first mandibular repositioning based on the first distance when the first splint fits onto the dentition and the opposing splint fits onto the opposing dentition, and contact the second fin to reposition the mandible as a second mandibular repositioning based on the second distance when the second splint fits onto the dentition and the opposing splint fits onto the opposing dentition.

6. The set of splints of claim 5 , wherein the first and second mandibular repositionings are in increments of from between about 0.5 mm to about 6.0 mm.

7. The set of splints of claim 5 , wherein the first mandibular repositioning is a repositioning prescribed by a doctor, and the second mandibular repositioning is a non-zero increment from the first mandibular repositioning.

8. The set of splints of claim 5 , wherein the total number of the set of splints is at least four to generate a third combination to generate a third mandibular repositioning when two splints among the set of splints are worn at the same time by the patient, wherein the third mandibular repositioning is different than the first mandibular repositioning and the second mandibular repositioning.

9. The set of splints of claim 8 , wherein the first, second and third mandibular repositionings each differ by an increment of from about 0.5 mm to about 6.0 mm, in no particular order.

10. The set of splints of claim 6 , wherein the first mandibular repositioning is a mandibular repositioning prescribed by a doctor, and the second mandibular repositioning and third mandibular repositioning are nonzero increments from the first mandibular repositioning.

11. The set of splints of claim 1 , wherein one imprint or image of the dentition is used to make the first splint or the second splints, or one imprint or image of the opposing dentition is used to make the opposing dentition.

12. The set of splints of claim 1 , wherein the first splint, the second splint, and the opposing splint independently comprise an open center, wherein the open center provides room for a tongue of the patient when wearing the first splint, the second splint, or the opposing splint.

13. The set of splints of claim 1 , wherein the first splint, the second splint, the opposing splint, or a combination thereof are milled using a milling machine using a computer aided design (CAD) file to direct the milling such that the accuracy of data from an impression of a patient's anatomy, a fit, and the design of the first splint, the second splint, the opposing splint, or the combination thereof are transferred to a milling machine.

14. The set of splints of claim 1 , wherein the first splint, the second splint, the opposing splint, or a combination thereof comprise a ball clasps and/or a retention arms.

15. The set of splints of claim 1 , wherein the first fin or the second fin is affixed to a first splint buccal to a buccal surface of maxillary teeth, and the opposing fin is affixed to an opposing splint buccal to a buccal surface of mandibular teeth.

16. The set of splints of claim 15 , wherein

(a) the first fin or the second fin is affixed to the first splint buccal to the buccal surface of maxillary teeth, and when the first splint or the second splint is fit onto maxillary dentition the first fin or the second fin protrudes downward below the occlusal plane of the first splint;

(b) the opposing fin is affixed to the second splint buccal to the buccal surface of mandibular teeth, and when the opposing splint is fit onto mandibular dentition the opposing fin protrudes upward above the occlusal plane of the opposing splint; or

(c) a combination of (a) and (b).

17. The set of splints of claim 1 , wherein a rake angle of the first fin or the second fin front surface or a rake angle of the opposing fin back surface is selected from the group consisting of a neutral angle, a recline angle, and a procline angle.

18. The set of splints of claim 1 , wherein the first or second splint and the opposing splint are placed on the maxillary and mandibular dentition, respectively, and the patient's mouth is closed, the first or second splint and the opposing splint contact each other along a plane substantially similar to the patient's occlusal plane.

19. The set of splints of claim 1 , wherein the first or second splint and the opposing splint comprise a transparent material.

20. The set of splints of claim 1 , wherein a gap is formed between the first fin and the first splint;

a gap is formed between the second fin and the second splint;

a gap is formed between the opposing fin and the opposing splint;

or any combination thereof.

Assignments (4)
SECURITY INTEREST Recorded Feb 18, 2026
From: PROSOMNUS SLEEP TECHNOLOGIES, INC.
To: ANKURA TRUST COMPANY, LLC, AS ADMINISTRATIVE AND COLLATERAL AGENT
Reel/Frame 073816/0221 →
RELEASE OF SECURITY INTEREST Recorded Feb 17, 2026
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS COLLATERAL AGENT
To: PROSOMNUS SLEEP TECHNOLOGIES, INC.
Reel/Frame 073810/0544 →
SECURITY INTEREST Recorded Aug 5, 2024
From: PROSOMNUS SLEEP TECHNOLOGIES, INC.
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS AGENT
Reel/Frame 068181/0258 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 12, 2024
From: KIM, SUNG; KUHNS, DAVID W.; LIPTAK, LEONARD A.
To: PROSOMNUS SLEEP TECHNOLOGIES, INC.
Reel/Frame 066443/0847 →
Continuity (9)
Continuation 18113012 · Feb 22, 2023
Continuation 17667439 · Feb 8, 2022
Continuation 15987816 · May 23, 2018
Continuation 15913548 · Mar 6, 2018
Continuation 15416666 · Jan 26, 2017
Continuation 14809208 · Jul 25, 2015
Continuation PCTUS2014072398 · Dec 24, 2014
Provisional Application 61922016 · Dec 30, 2013
Related Publication 20240325192A1 · Oct 3, 2024
References Cited (87)
US 4671766A · Norton · 1987 [cited by applicant]
US 4708646A · Jasper · 1987 [cited by applicant]
US 5313960A · Tomasi · 1994 [cited by applicant]
US 5352116A · West · 1994 [cited by applicant]
US 5365945A · Halstrom · 1994 [cited by applicant]
US 5427117A · Thornton · 1995 [cited by applicant]
US 5566683A · Thornton · 1996 [cited by applicant]
US 5611355A · Hilsen · 1997 [cited by applicant]
US 5868138A · Halstrom · 1999 [cited by applicant]
US 6041784A · Halstrom · 2000 [cited by applicant]
US 6055986A · Meade · 2000 [cited by applicant]
US 6161542A · Halstrom · 2000 [cited by applicant]
US 6413082B2 · Binder · 2002 [cited by applicant]
US 6418933B1 · Strong · 2002 [cited by applicant]
US 6516805B1 · Thornton · 2003 [cited by applicant]
US 6526982B1 · Strong · 2003 [cited by applicant]
US 6604527B1 · Palmisano · 2003 [cited by applicant]
US 6729335B1 · Halstrom · 2004 [cited by applicant]
US 7013191B2 · Rubbert et al. · 2006 [cited by applicant]
US 7146982B2 · Mousselon et al. · 2006 [cited by applicant]
US 7637262B2 · Bailey · 2009 [cited by applicant]
US D639440S · Raad · 2011 [cited by applicant]
US 8001973B2 · Sotos et al. · 2011 [cited by applicant]
US 8025063B2 · Sotos et al. · 2011 [cited by applicant]
US 8037886B2 · Sotos et al. · 2011 [cited by applicant]
US 8136529B2 · Kelly · 2012 [cited by applicant]
US 8205617B2 · Scarberry et al. · 2012 [cited by applicant]
US 8215312B2 · Garabadian et al. · 2012 [cited by applicant]
US 8226569B2 · Sotos et al. · 2012 [cited by applicant]
US 8267093B2 · Marie-Catherine · 2012 [cited by applicant]
US 8312884B2 · Fuselier · 2012 [cited by applicant]
US 9545332B2 · Luco · 2017 [cited by examiner]
US 9820882B2 · Liptak et al. · 2017 [cited by applicant]
US 11129745B2 · Remmers et al. · 2021 [cited by applicant]
US 11534331B2 · Veis · 2022 [cited by examiner]
US 20070183572A1 · Drummond et al. · 2007 [cited by applicant]
US 20070283967A1 · Bailey · 2007 [cited by applicant]
US 20100316973A1 · Remmers et al. · 2010 [cited by applicant]
US 20110005527A1 · Andrew et al. · 2011 [cited by applicant]
US 20110220125A1 · Van Dyke · 2011 [cited by examiner]
US 20110308531A1 · Grosky · 2011 [cited by applicant]
US 20120227750A1 · Tucker · 2012 [cited by examiner]
US 20130014765A1 · Meade · 2013 [cited by applicant]
US 20130112210A1 · Stein · 2013 [cited by examiner]
US 20140076332A1 · Luco · 2014 [cited by applicant]
US 20140326252A1 · Quaka et al. · 2014 [cited by applicant]
US 20150007830A1 · Remmers et al. · 2015 [cited by applicant]
US 20150075540A1 · Dye · 2015 [cited by examiner]
US 20160228286A1 · Rayek et al. · 2016 [cited by applicant]
US 20180168845A1 · Hofmann · 2018 [cited by examiner]
US 20180360646A1 · Bedford · 2018 [cited by applicant]
US 20200000625A1 · Robichaud et al. · 2020 [cited by applicant]
US 20200163795A1 · Garcia Reyes et al. · 2020 [cited by applicant]
DE 102004007008A · 2008 [cited by applicant]
GB 2494935A · 2013 [cited by applicant]
JP H04183462A · 1992 [cited by applicant]
JP 2002519137A · 2002 [cited by applicant]
JP 2003038520A · 2003 [cited by applicant]
JP 2005503235A · 2005 [cited by applicant]
JP 2005304904A · 2005 [cited by applicant]
JP 2007503874A · 2007 [cited by applicant]
JP 2011520533A · 2011 [cited by applicant]
KR 20130111848 · 2013 [cited by applicant]
RU 2491041C1 · 2013 [cited by applicant]
WO 2009140720A1 · 2009 [cited by applicant]
WO 2013102095A1 · 2013 [cited by applicant]
WO 2013124452A1 · 2013 [cited by applicant]
Notice of Allowance for U.S. Appl. No. 14/809,208, dated Mar. 16, 2017. [cited by applicant]
Partial European Search Report and Provisional Opinion for EP App No. 14877266, dated Jul. 24, 2017. [cited by applicant]
Office Action for CA App No. 2,934,824, Sep. 17, 2021. [cited by applicant]
Examination report No. 1 for AU App No. 2014373973, Oct. 17, 2018. [cited by applicant]
Non-Final Office Action for U.S. Appl. No. 15/987,816, dated Apr. 29, 2020, 15 pgs. [cited by applicant]
International Search Report and Written Opinion for PCT App No. PCT/US2014/072398, dated May 21, 2015, 6 pgs. [cited by applicant]
International Preliminary Report on Patentability for PCT App No. PCT/US2014/072398, dated Jul. 5, 2016, 5 pgs. [cited by applicant]
Bloch, K.E., et al., A Randomized, Controlled Crossover Trial of Two Oral Appliances for Sleep Apnea Treatment, Am J Respir Crit Care Med, vol. 162, pp. 246-251, 2000. [cited by applicant]
Demko, B.G., 2013 Oregon Dental Conference. Course 3106: Obstructive Sleep Apnea: A Whirlwind Tour, Lecture Slides; Apr. 4, 2013. [cited by applicant]
Fritsch, K.M., et al., Side Effects of Mandibular Advancement Devices for Sleep Apnea Treatment, Am J Respir Crit Care Med, vol. 164, pp. 813-818, 2001. [cited by applicant]
Lin, T-Y & Lee, Y-U, Patents Analysis and Design Suggestions for the Mandibular Advancement Devices, Taiwan International Journal of Medical and Biological Sciences, vol. 6, 103-108, 2012. [cited by applicant]
Lowe, A.A., Dental Appliances for the Treatment of Snoring and Obstructive Sleep Apnea, Ch. 69 in Principles and Practice of Sleep Medicine, 2nd Ed.; edited by Kryger, MH, et al.; 1994; W.B. Saunders Company, Philadelph… [cited by applicant]
Mehta, A., et al., A Randomized Controlled Study of a Mandibular Advancement Splint for Obstructive Sleep Apnea, Am J Respir Crit Care Med, vol. 163, pp. 1457-1461, 2001. [cited by applicant]
Nordstrom, D., The NorSnor-2, Jun. 1994. [cited by applicant]
O'Sullivan, R.A., et al., Mandibular Advancement Splint: An Appliance to Treat Snoring and Obstructive Sleep Apnea, Am J Respir Crit Care Med, vol. 151, pp. 194-198, 1995. [cited by applicant]
Tan, Y.K., et al., Mandibular Advancement Splints and Continuous Positive Airway Pressure in Patients with Obstructive Sleep Apnea, A Randomized Cross-Over Trial, European Journal of Orthodontics 24 (2002) 239-249. [cited by applicant]
Wahl, N., Orthodontics in 3 Millenia. Chapter 9: Functional Appliances to Midcentury, Am J Orth and Dentofacial Orthopedics, vol. 129, No. 6, 829-833; 2006. [cited by applicant]
Office Action issued by the JPO in Japanese Patent Application No. 2016-544540 dated May 14, 2019—incl Engl lang transl (13 pages total). [cited by applicant]
Office Action for EP 14877266.8, Jul. 22, 2020. [cited by applicant]
Office Action for CA App No. 2,934,824, dated Aug. 21, 2024, 5 pgs. [cited by applicant]