Apparatus and method for manufacturing a mandibular advancement device

Abstract

The present disclosure relates to a method for treating sleep disorders using an intra-oral appliance and to the fabrication of an intra-oral appliance that incorporates digital information into the process so as to increase efficiency and decrease cost. The method includes a data capture step and a fabrication step.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a mandibular advancement device manufactured in accordance with an embodiment of the present invention;

FIG. 2 is a flow diagram of the major steps of the fabrication process of the mandibular advancement device of FIG. 1;

FIG. 3 is a view of a Data Capture Unit used in the method of manufacture in accordance with one embodiment of the invention, shown in a first orientation;

FIG. 4 is a view of the Data Capture Unit of FIG. 3 in a second orientation;

FIG. 5 shows four images taken by the Data Capture Unit of FIG. 3;

FIG. 6 shows an optical impression device used in accordance with one embodiment of the present invention;

FIG. 7 shows a virtual model obtained using the optical impression system of FIG. 6;

FIG. 8 shows a computer console with drawing tablet for use in a parameter definition step in accordance with one embodiment of the present invention;

FIG. 9 is a screenshot of parameter definition software used in the method of manufacture;

FIG. 10 is a screenshot of the parameter definition software of FIG. 9, showing a dental professional defining various parameters;

FIG. 11 shows the manner in which defined parameters are used to create a three-dimensional wireframe virtual model of the upper and lower shells in accordance with one embodiment of the present invention;

FIG. 12 is a screenshot of the three-dimensional wireframe virtual model of the upper and lower shells in accordance with one embodiment of the present invention;

FIG. 13 shows a milling machine unit in accordance with one embodiment of the present invention;

FIG. 14 shows a milling operation in which a shell is milled from a generic shell template in accordance with one embodiment of the invention;

FIG. 15 shows a heated moldable material being inserted into a channel of a shell in accordance with one embodiment of the present invention;

FIG. 16 shows the moldable material and shell of FIG. 15 being placed into engagement with a physical dental model in accordance with one embodiment of the present invention;

FIG. 17 shows a shell mold produced by a rapid prototyping machine according to one embodiment of the present invention;

FIG. 18 shows a shell having a mechanical locking mechanism in accordance with one embodiment of the present invention;

FIG. 19 shows the moldable material and shell of FIG. 15 being placed into engagement with a physical dental model using a lever and base unit in accordance with an embodiment of the present invention; and

FIG. 20 shows the moldable material and shell of FIG. 15 being placed into engagement directly with a patient's teeth in accordance with another embodiment of the present invention.

Claims

1. A method of forming a mandibular advancement device comprising: acquiring electronic information relating to a patient's maxillary and mandibular dentitions;fabricating an upper shell for the patient's maxillary dentition and a lower shell for the patient's mandibular dentition based upon the electronic information, each of the shells formed of a first material and having a channel therein, a coupling device being provided on the upper shell and the lower shell for maintaining the lower shell in a forwardly protruded position with respect to the upper shell when taken in relation to the corresponding natural position of the patient's mandibular and maxillary dentitions;supplying a moldable second material to the channels; andshaping the moldable second material to substantially conform to the patient's maxillary and mandibular dentitions.

2. The method according to claim 1, wherein the step of shaping the moldable second material is performed by placing the moldable second material over the patient's teeth or by placing the moldable second material over a model of the patient's teeth.

3. The method according to claim 1, wherein the step of acquiring information relating to a patient's maxillary and mandibular dentitions in electronic form is performed by (a) taking a three-dimensional scan of the patient's oral cavity or (b) taking digital photographs of a dental model.

4. The method according to claim 1, wherein the electronic information is transmitted to a third party.

5. The method according to claim 4, wherein the third party fabricates the upper and lower shells.

6. The method according to claim 1, wherein the step of fabricating an upper shell and a lower shell based upon the electronic information comprises defining upper and lower shell parameters.

7. The method according to claim 6, wherein the step of defining upper and lower shell parameters is performed by a computer program upon receiving the electronic information.

8. The method according to claim 6, wherein a milling machine receives the upper and lower shell parameters and mills the upper shell out of a generic upper shell template and the lower shell out of a generic lower shell template.

9. The method according to claim 8, wherein first and second retention elements of the coupling device are secured to the respective generic templates prior to milling.

10. The method according to claim 6, wherein the step of fabricating an upper shell and a lower shell based upon the electronic information comprises the steps of: producing an upper mold and a lower mold for shaping the first material according to the defined upper and lower shell parameters; andinjecting the first material into the upper and lower molds to form the upper and lower shells.

11. The method according to claim 1, wherein the coupling device is positioned based upon the electronic information.

12. The method according to claim 1, wherein the coupling device comprises: (1a) an upper retention element secured to the upper shell,(2a) a lower retention element secured to the lower shell,(3a) a guide box, and(4a) a stylus, wherein the guide box is connected to one of the upper retention element or the lower retention element, the stylus is connected to the other of the upper retention element or the lower retention element, the guide box and the stylus configured to engage each other to provide lateral relative movement between the upper shell and the lower shell; orwherein the coupling device comprises: (2a) an upper flange extending from the upper shell, and(2b) a lower flange extending from the lower shell, wherein the upper flange and the lower flange engage each other to maintain the lower shell in the forwardly protruding position; orwherein the coupling device comprises: (3a) a post extending from one of the upper shell or the lower shell, the post engaging the other of the upper shell or the lower shell to maintain the lower shell in the forwardly protruding position; orwherein the coupling device comprises: (4a) elastic bands biased to urge the lower shell forwardly.

13. The method according to claim 1, wherein the coupling device connects, at one end, to a forward region of one of the upper shell or the lower shell and, at another end, the coupling device connects to a rearward region of the other of the upper shell or the lower shell.

14. The method according to claim 1, wherein the coupling device is (a) separately formed and secured to the upper shell and the lower shell by a fastening mechanism, or (b) integrally formed with one or both of the upper shell and the lower shell.

15. The method according to claim 1, wherein the coupling device is a Halstrom hinge, a Thornton device, a Lowe device, a Palmisano device, Frantz device, or any combination thereof.

16. A method of forming a mandibular advancement device comprising: acquiring electronic information relating to a patient's maxillary and mandibular dentitions; andfabricating an upper bite block for the patient's maxillary dentition and a lower bite block for the patient's mandibular dentition based upon the electronic information, a coupling device being provided on the upper bite block and the lower bite block for maintaining the lower bite block in a forwardly protruded position with respect to the upper bite block when taken in relation to the corresponding natural position of the patient's mandibular and maxillary dentitions.

17. The method according to claim 16, wherein the bite block is formed out of a single material.

18. The method according to claim 16, wherein the bite block is formed out of at least a hard acrylic and a soft acrylic.

19. The method according to claim 16, wherein the step of acquiring information relating to a patient's maxillary and mandibular dentitions in electronic form is performed by (a) taking a three-dimensional scan of the patient's oral cavity or (b) taking digital photographs of a dental model.

20. The method according to claim 19, wherein the electronic information is transmitted to a third party.

21. The method according to claim 20, wherein the third party fabricates the upper and lower bite blocks.

22. The method according to claim 16, wherein the step of fabricating an upper bite block and a lower bite block based upon the electronic information comprises defining parameters.

23. The method according to claim 22, wherein the step of defining parameters is performed by a computer program upon receiving the electronic information.

24. The method according to claim 22, wherein a milling machine receives the defined parameters and mills at least part of the upper bite block out of a generic upper template and at least part of the lower bite block out of a generic lower template.

25. The method according to claim 24, wherein first and second retention elements of the coupling device are secured to the respective generic templates prior to milling.

26. The method according to claim 22, wherein the step of fabricating an upper bite block and a lower bite block based upon the electronic information comprises the steps of: producing an upper mold and a lower mold for shaping a material according to the defined parameters; andinjecting the material into the upper and lower molds to form at least part of the upper and lower bite blocks.

27. The method according to claim 16, wherein the coupling device is positioned based upon the electronic information.

28. The method according to claim 16, wherein the coupling device comprises: (1a) an upper retention element secured to the upper bite block,(1b) a lower retention element secured to the lower bite block,(1c) a guide box, and(1d) a stylus, wherein the guide box is connected to one of the upper retention element or the lower retention element, the stylus is connected to the other of the upper retention element or the lower retention element, the guide box and the stylus configured to engage each other to provide lateral relative movement between the upper bite block and the lower bite block; orwherein the coupling device comprises: (2a) an upper flange extending from the upper bite block, and(2b) a lower flange extending from the lower bite block, wherein the upper flange and the lower flange engage each other to maintain the lower bite block in the forwardly protruding position; orwherein the coupling device comprises: (3a) a post extending from one of the upper bite block or the lower bite block, the post engaging the other of the upper bite block or the lower bite block to maintain the lower bite block in the forwardly protruding position; orwherein the coupling device comprises: (4a) elastic bands biased to urge the lower shell forwardly.

29. The method according to claim 16, wherein the coupling device connects, at one end, to a forward region of one of the upper bite block or the lower bite block and, at another end, the coupling device connects to a rearward region of the other of the upper bite block or the lower bite block.

30. The method according to claim 16, wherein the coupling device is (a) separately formed and secured to the upper bite block and the lower bite block by a fastening mechanism, or (b) integrally formed with one or both of the upper bite block and the lower bite block.

31. The method according to claim 16, wherein the coupling device is a Halstrom hinge, a Thornton device, a Lowe device, a Palmisano device, Frantz device, or any combination thereof.