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US-12616428-B2 - Automated method of manufacturing oral appliances

US12616428B2US 12616428 B2US12616428 B2US 12616428B2US-12616428-B2

Abstract

Disclosed herein are methods of manufacturing an oral appliance, the method comprising the steps of: a) importing into a computer aided design (CAD) computer program a digitized data set obtained from a three-dimensional scan of a patient's dentition; b) preparing a three-dimensional electronic model of the patient's dentition; c) subtracting the three-dimensional electronic model of the patient's dentition from an image of a solid block to obtain an appliance data set; and d) manufacturing a dental appliance in accordance with the appliance data set. Also disclosed are devices made by the above method, and methods of treating a condition, for example a sleep breathing disorder, by using a device made by the above method.

Inventors

  • Sung Kim
  • David W. Kuhns
  • Leonard A. LIPTAK

Assignees

  • PROSOMNUS SLEEP TECHNOLOGIES INC.

Dates

Publication Date
20260505
Application Date
20230317

Claims (20)

  1. 1 . A method of manufacturing an oral appliance, the method comprising the steps of: a) preparing a three-dimensional electronic model of dentition of a patient; b) determining a contour curve for the dentition; c) subtracting the three-dimensional electronic model of a patient's dentition from an image of a solid block to obtain an appliance data set comprising data associated with a portion corresponding to an appliance accessory in or coupled to the oral appliance, a portion to attach the appliance accessory to the oral appliance, or a connection point to connect the appliance accessory, wherein the appliance accessory comprises an electronic chip or an electronic or microelectronic device; and d) manufacturing a dental appliance in accordance with the appliance data set and the contour curve.
  2. 2 . The method of claim 1 , further comprising the step of superimposing the image of a solid block over one of upper or lower dentition of the patient prior to the subtracting step.
  3. 3 . The method of claim 2 , wherein the solid block is superimposed such that a gingival surface of the solid block is at approximately the height of contour of a molar tooth of the dentition.
  4. 4 . The method of claim 1 , wherein a contour curve is placed at an offset distance at either a buccal or lingual side of the dentition, wherein the offset distance is a fraction of a visible buccal or lingual height of one of a posterior-most molars.
  5. 5 . The method of claim 4 , further comprising the step of moving the contour curve towards a gingival line by a distance that is a fraction of the visible buccal or lingual height of one of the posterior-most molars.
  6. 6 . The method of claim 5 , further comprising the step of subtracting the portion of the solid block below the contour curve to obtain a contoured block.
  7. 7 . The method of claim 6 , wherein the contoured block is the solid block used in the subtracting step.
  8. 8 . The method of claim 5 , wherein the contour curve is moved by between about 0 to about 100% of a tooth height.
  9. 9 . The method of claim 4 , wherein the offset distance is between about 0 to about 100% of a tooth height.
  10. 10 . The method of claim 1 , wherein the solid block has a shape that approximates a shape of the dental appliance.
  11. 11 . The method of claim 1 , further comprising repeating steps c) and d) for the other of the patient's upper or lower dentition.
  12. 12 . The method of claim 1 , wherein a digitized data set is obtained from: i) scanning a model of the patient's dentition; ii) the patient's dentition directly; iii) X-ray image of the patient's dentition; iv) computed tomographic (CT) scan of the patient's dentition; or v) digitized photographs of the patient's dentition.
  13. 13 . The method of claim 1 , wherein the appliance accessory comprises a compliance chip, an electronic or microelectronic device, or an electronic device configured to obtain data and communicate the data with another electronic device.
  14. 14 . The method of claim 1 , wherein the appliance accessory is selected from the group consisting of fin, strap, affixed sleeve, removable sleeve, straps, anterior hinge, short or long Herbst, jack screw, and Herbst hinge in combination with jack screw.
  15. 15 . The method of claim 1 , wherein the appliance accessory comprises an electronic device configured to obtain data and communicate the data with another electronic device.
  16. 16 . The method of claim 1 , wherein the appliance is manufactured automatically by a method selected from the group consisting of milling a block, injection molding, three-dimensional printing, computer aided manufacturing technology and hand carving.
  17. 17 . An oral appliance manufactured by the method of claim 1 .
  18. 18 . A method of treating or ameliorating a condition in a patient, the method comprising: identifying a patient in need thereof, obtaining the oral appliance manufactured by the method of claim 1 , and positioning the oral appliance in the patient's mouth, such that the condition is treated or ameliorated; wherein the condition is one in which the repositioning of the patient's dentition treats or ameliorates the condition.
  19. 19 . The method of claim 18 , wherein the condition is selected from the group consisting of sleep apnea, teeth grinding, and improperly positioned mandible.
  20. 20 . A method of manufacturing a splint for a mandibular advancement device, the method comprising the steps of: a) preparing a three-dimensional electronic model of a patient's dentition; b) superimposing an image of a solid block over the electronic model of one of the patient's upper or lower dentition, wherein the solid block has a “U” shape that approximates the curvature of the patient's dentition, and whereby a gingival surface of the solid block is at about a height of contour of a molar tooth of the dentition; d) determining the contour curve for the dentition, wherein a contour curve is placed at an offset distance at either a buccal or lingual side of the dentition, wherein the offset distance is between about 20% to about 80% of a visible tooth height of one of the posterior-most molars; e) moving the height of contour curve towards a gingival line by a distance of about between about 1% to about 50% of the visible tooth height of one of the posterior-most molars; f) subtracting the portion of the solid block below the height of contour curve to obtain a contoured block; g) subtracting the three-dimensional electronic model of the patient's dentition from the contoured block to obtain an appliance data set comprising data associated with a portion corresponding to an appliance accessory in or coupled to the oral appliance, a portion to attach the appliance accessory to the oral appliance, or a connection point to connect the appliance accessory, wherein the appliance accessory comprises an electronic chip or an electronic or microelectronic device; h) automatically manufacturing a dental appliance in accordance with the appliance data set.

Description

RELATED APPLICATIONS The present application is a continuation of U.S. patent application Ser. No. 17/374,587, filed Jul. 13, 2021, now U.S. Pat. No. 11,607,183, which is a continuation of U.S. patent application Ser. No. 16/285,113, filed Feb. 25, 2019, which is a continuation of U.S. patent application Ser. No. 15/789,582, filed Oct. 20, 2017, now U.S. Pat. No. 10,213,280, which is a continuation of U.S. patent application Ser. No. 15/416,715, filed Jan. 26, 2017, which claims priority to U.S. Provisional Application Serial No. 62/365,974, filed Jul. 22, 2016, the entire disclosure of each of which is incorporated by reference herein. FIELD OF THE INVENTION This invention is in the field of digitized design and manufacture of an oral appliance. BACKGROUND OF THE DISCLOSURE Oral appliances, such as mandibular advancement devices, bruxing packages, AM positioners, and the like, are hand crafted to fit a plaster model of a patient's dentition. This process is laborious, leading to its high cost and inescapable variations from one device to another made by the same craftsperson, or from one craftsperson to another. If the initial device does not fit the patient well, or if the accessories are incorrectly placed, then the craftsperson must make a new device by hand crafting it from what is typically referred to as the “salt and pepper” method. This has a technician mixing the monomer of acrylate with the polymer of acrylate in a build-up process to create the oral appliance from scratch. The technician aligns, visually and with the aid of a ruler, the different components of the device, including the relative position of the titration mechanism to the patient's dentition and the relative position of bilateral components to each other, for example the placement of two jack screws situated at patient left and right. The fit of the device on the dentition uses a classic process borrowed from the manufacture of dentures called “block out.” Block out refers to the process of filling in the undercut of each tooth below the height of contour (see below for definition). The technician visually measures the amount of the undercut to block out to create just the right retention, not too much, not too little. A pencil or pen is used to draw a line along the height of contour and then blocking material such as dental putty is filled under that line. The thickness of that pencil line is typically on the order of 0.5 mm to 1.0 mm and each technician may place that line in a different position. This cumulative error in defining dimensions is common in the dental laboratory and is very often accommodated for by the dentist with the patient in the chair by using a dental burr to adjust the appliance fit. Additionally, the cumulative error of the “salt and pepper” method and placement of the titration mechanism is accommodated for by the dentist, with the patient in the chair, by adjusting the titration mechanism, such as a jack screw. The adjustment repositions the relationship of the upper and lower splints to the desired position as requested by the dentist originally when submitting the patient data to the laboratory. It is a common practice that in case of a broken splint, an entire new upper and lower device needs to be made. Building a single splint to fit with an existing opposing splint is too difficult considering the accumulated errors in the process. In addition to being time-consuming, the inadvertent and inescapable variations between the original device and the new one introduce additional problems. For instance, in some applications where an exact positional difference between one feature of one splint and the corresponding feature of another splint cannot be properly determined because a handcrafted device exhibits inadvertent positional differences elsewhere that make the intended positional difference become a priori unmeasurable. Medicare guidelines require an oral appliance for the treatment of obstructive sleep apnea (OSA) per the E0486 code, to have adjustments capability of 1.0 mm or less Clinical significance of titration adjustment has been shown by Almeida et. Al (reference) to be 0.5 mm or less. The challenge for dental and medical practitioners is to efficiently treat patients using small titration increments with oral appliances that have cumulative errors greater than what is clinically significant. Additionally, the cumulative error in all the x, y, and z axes can improperly position the appliance in the patient's mouth and affect the mandibular position as well. The repositioning can potentially lead to unwanted issues, or an exacerbation thereof, such as changes in the temporal mandibular joint (TMJ) or orthodontic tooth movements. Thus much time and treatment duration is wasted managing the appliance instead of managing the disease. SUMMARY OF THE INVENTION Disclosed herein are methods of manufacturing an oral appliance, the method comprising the steps of: a) preparing a three-dimensional elec