SYSTEMS FOR MANUFACTURING ORAL-BASED HEARING AID APPLIANCES

• US 20080070181A1
• Filed: 08/20/2007
• Published: 03/20/2008
• Est. Priority Date: 08/22/2006
• Status: Active Grant

• Current Assignee: Sonitus Medical, Inc.
• Original Assignee: Sonitus Medical, Inc.
• Inventors: Abolfathi, Amir, Phan, Loc
• Granted Patent: US 8,291,912 B2
• Time in Patent Office: Days
• US Class Current: 433/6
• CPC Class Codes: A63B 71/085 Mouth or teeth protectors A63B71/081 takes precedence
• CPC Class Codes: B33Y 50/00 Data acquisition or data processing for additive manufacturing
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: H04R 2225/77 Design aspects, e.g. CAD, of hearing aid tips, moulds or housings
• CPC Class Codes: H04R 2460/13 Hearing devices using bone conduction transducers
• CPC Class Codes: H04R 25/606 acting directly on the eardrum, the ossicles or the skull, e.g. mastoid, tooth, maxillary or mandibular bone, or mechanically stimulating the cochlea, e.g. at the oval window
• CPC Class Codes: H04R 25/658 Manufacture of housing parts

Abstract

Systems for manufacturing oral-based hearing aid appliances utilizing various manufacturing methods and apparatus are described herein. The oral appliance may have an electronic and/or transducer assembly for receiving incoming sounds and transmitting processed sounds via a vibrating transducer element coupled to a tooth or teeth. The oral appliance may be formed or fabricated via three-dimensional digital scanning systems or via impression molding to create a housing for the electronics and/or transducer assembly as well as to securely conform the appliance to the user'"'"'s dentition.

Claims

1. A method for fabricating an oral appliance for maintaining an electronics and/or transducer assembly against at least a portion of a patient'"'"'s dentition, comprising:

scanning at least the portion of dentition such that a corresponding three-dimensional image is created;

manipulating the image such that a housing is positioned along a side surface of the portion of dentition; and

forming the oral appliance having the housing portion from the image whereby the oral appliance is conformable to the portion of dentition.

2. The method of claim 1 wherein scanning comprises scanning via an imaging modality selected from the group consisting of laser, white light, ultrasound, mechanical three-dimensional touch scanners, magnetic resonance imaging, and computed tomography.

3. The method of claim 1 wherein scanning comprises scanning via an intra-oral digital camera.

4. The method of claim 1 wherein scanning comprises generating a corresponding three-dimensional digital image.

5. The method of claim 1 wherein manipulating comprises digitally adding via a computer a housing sized for the electronics and/or transducer assembly.

6. The method of claim 1 wherein forming comprises creating the oral appliance corresponding to the image via a process selected from the group consisting of machining, computer numerical control machining, stereolithography apparatus, and selective laser sintering.

7. The method of claim 6 wherein creating comprises forming a positive mold corresponding to the oral appliance having the housing portion.

8. The method of claim 7 further comprising thermal forming the oral appliance over the positive mold.

9. The method of claim 1 wherein forming comprises injecting a polymer into a cavity formed between an inner mold portion and an outer mold portion whereby the cavity defines a configuration of the oral appliance.

10. A method for fabricating an oral appliance for maintaining an electronics and/or transducer assembly against at least a portion of a patient'"'"'s dentition, comprising:

adhering a housing along a side surface of the portion of dentition;

scanning at least the portion of dentition having the housing such that a corresponding three-dimensional image is created; and

forming the oral appliance having the housing portion from the image whereby the oral appliance is conformable to the portion of dentition.

11. The method of claim 10 wherein adhering comprises temporarily affixing the housing along a buccal surface of the portion of dentition.

12. The method of claim 10 wherein scanning comprises scanning via an imaging modality selected from the group consisting of laser, white light, ultrasound, mechanical three-dimensional touch scanners, magnetic resonance imaging, and computed tomography.

13. The method of claim 10 wherein scanning comprises scanning via an intra-oral digital camera.

14. The method of claim 10 wherein scanning comprises generating a corresponding three-dimensional digital image.

15. The method of claim 10 wherein forming comprises creating the oral appliance corresponding to the image via, a process selected from the group, consisting of machining, computer numerical control machining, stereolithography apparatus, and selective laser sintering.

16. The method of claim 15 wherein creating comprises, forming a positive mold corresponding to the oral appliance.

17. The method of claim 16 further comprising thermal forming the oral appliance over the positive mold.

18. The method of claim 10 wherein forming comprises injecting a polymer into a cavity formed between an inner mold portion and an outer mold portion whereby the cavity defines a configuration of the oral appliance.

19. A method for fabricating an oral appliance for maintaining an electronics and/or transducer assembly against at least apportion of a patient'"'"'s dentition, comprising:

obtaining an impression of at least the portion of dentition;

scanning the impression such that a corresponding three-dimensional image is created;

manipulating the image such that a housing is positioned along a side surface of the portion of dentition; and

forming the oral appliance having the housing portion from the image whereby the oral appliance is conformable to the portion of dentition.

20. The method of claim 19 wherein obtaining an impression comprises impressing a mold upon the portion of dentition.

21. The method of claim 19 wherein obtaining an impression comprises modality selected from the group consisting of laser, white light, ultrasound, mechanical three-dimensional touch scanners, magnetic resonance imaging, and computed tomography.

22. The method of claim 19 wherein scanning comprises scanning via an intra-oral digital camera.

23. The method of claim 19 wherein scanning comprises generating a corresponding three-dimensional digital image.

24. The method of claim 19 wherein manipulating comprises digitally adding via a computer a housing sized for the electronics and/or transducer assembly.

25. The method of claim 19 wherein forming comprises creating the oral appliance corresponding to the image via a process selected from the group consisting of machining, computer numerical control machining, stereolithography apparatus, and selective laser sintering.

26. The method of claim 25 wherein creating comprises forming a positive mold corresponding to the oral appliance having the housing portion.

27. The method of claim 26 further comprising thermal forming the oral appliance over the positive mold.

28. A method for fabricating an oral appliance for maintaining an electronics and/or transducer assembly against at least a portion of a patient'"'"'s dentition, comprising:

providing a dental tray sized to cover at least the portion of the patient'"'"'s dentition,

providing a dental tray sized to cover at least the portion of the patient'"'"'s dentition, wherein the dental tray defines a housing for the electronics and/or transducer assembly;

filling a channel defined along the dental tray with a settable polymer;

placing at least the portion of the patient'"'"'s dentition within the channel such that the polymer conforms to a shape of the dentition until the polymer hardens; and

removing the dental tray from the hardened polymer.

29. The method of claim 28 further comprising trimming the hardened polymer.

30. The method of claim 28 wherein providing comprises providing the dental tray having the electronics and/or transducer assembly contained within the housing.

31. The method of claim 30 wherein filling comprises filling the channel via a dispenser such that the electronics and/or transducer assembly is at least partially encapsulated by the polymer within the housing.

32. The method of claim 28 wherein placing further comprises activating the polymer such that the polymer hardens.

33. The method of claim 28 further comprising attaching the electronics and/or transducer assembly to the hardened polymer within the housing.

34. The method of claim 28 further comprising forming a scaffold using a rapid prototyping system.

35. The method of claim 34, wherein the rapid prototyping system comprises one of:

fused deposition modeling system, selective laser sintering system, 3-D printing system, inkjet printing system.

36. The method of claim 34, comprising coating the scaffold with a resin to strengthen the scaffold.

37. A blank for use in making a direct-formed mouthguard, said blank comprising:

a material conformable to a contours of a user'"'"'s intra-oral structures at a predetermined temperature range when said blank is subjected to bite pressure; and

a transducer assembly mounted on said material to couple to at least a portion of a patient'"'"'s dentition.

38. The method of claim 37, wherein the blank comprises an inner layer of settable thermoplastic material conformable to the contours of the user'"'"'s intra-oral structures at a predetermined temperature, range when said blank is subjected to bite pressure;

a core layer of rigid, force-transmitting thermoplastic material disposed adjacent to and coextensively with said inner layer and having a softening temperature higher than said pre-determined temperature range, said core layer conformable to the general shape pf the user'"'"'s upper or lower row of teeth at said softening temperature to adjust the overall fit of said blank, and

an outer layer of settable, shock-absorbing thermoplastic material disposed adjacent to and coextensively with said core layer, said outer layer conformable to the contours of a user'"'"'s intra-oral structures at said pre-determined temperature range when said blank is subjected to bite pressure.

39. The method of claim 37, wherein said transducer is inserted into said material before or after said blank is subjected to bite pressure.