Compliance monitor and method for a medical device

• US 8,771,149 B2
• Filed: 03/08/2006
• Issued: 07/08/2014
• Est. Priority Date: 10/01/2001
• Status: Active Grant

• Current Assignee: Align Technology Incorporated
• Original Assignee: Nemours Foundation
• Inventors: Rahman, Tariq, Shaffer, Thomas H., Bowen, J. Richard
• Primary Examiner(s): RICHMAN, GLENN E
• Application Number:
  US11/369,994
• Publication Number:
  US 20060166157A1
• Time in Patent Office: 3,044 Days
• Field of Search: 482 1- 11, 482900-902, 433/5, 433/6, 433/25, 433/27
• US Class Current: 482/8
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61C 19/04 Measuring instruments specially adapted for dentistry A61C5/44 takes precedence; testing vitality of teeth A61B5/0534; radiation diagnosis specially adapted for dentistry A61B6/51
• CPC Class Codes: A61C 7/00 Orthodontics, i.e. obtaining or maintaining the desired position of teeth, e.g. by straightening, evening, regulating, separating, or by correcting malocclusions

Abstract

An orthodontic compliance monitor includes a sensor that senses when an orthodontic appliance is properly positioned and a processor that processes an output of the sensor and generates compliance data. A memory device stores compliance data and the processor generates the compliance data based on a compliance protocol. System and methods for orthodontic compliance are also disclosed.

Claims

1. An orthodontic compliance monitor, comprising:

a sensor that senses when an orthodontic appliance is positioned in the mouth for use;

a processor that processes an output of said sensor and generates compliance data based on a compliance protocol; and

a memory device that stores the compliance data.

2. The orthodontic compliance monitor of claim 1, wherein said sensor comprises at least one of a temperature sensor, pressure sensor, moisture sensor, light sensor, or pH sensor.

3. The orthodontic compliance monitor of claim 1, wherein said processor comprises at least one of a micro controller, microprocessor, application specific integrated circuit, counter, or field programmable gate array.

4. The orthodontic compliance monitor of claim 1, further comprising an interface configured to output the compliance data as at least one of radio frequency signals, optical signals, or electrical signals.

5. The orthodontic compliance monitor of claim 1, further comprising an output device configured to output compliance data.

6. The orthodontic compliance monitor of claim 5, wherein said output device comprises a display that displays the compliance data.

7. The orthodontic compliance monitor of claim 1, wherein said compliance protocol comprises an amount of time the orthodontic appliance is to be worn over a period of time.

8. The combination of an orthodontic appliance and the orthodontic compliance monitor of claim 1.

9. The combination of claim 8, wherein said orthodontic appliance is one of an orthodontic brace, a retainer, a mouth guard, a bruxism treatment device, and a nightguard.

10. The orthodontic compliance monitor of claim 1, wherein the compliance monitor is configured to be at least one of removably coupled with an orthodontic appliance or physically incorporated into an orthodontic appliance.

11. A method of determining whether a user is using an orthodontic appliance, said method comprising the steps of:

sensing, using an electronic sensor positioned in the user'"'"'s mouth, when an orthodontic appliance is positioned for use in a user'"'"'s mouth to generate a digital output;

processing the output and generating compliance data based on a compliance protocol; and

storing the compliance data.

12. The orthodontic compliance monitor method of claim 11, wherein said step of sensing comprises sensing at least one of temperature, pressure, moisture, light, or pH.

13. The orthodontic compliance monitor method of claim 11, further comprising the step of:

transmitting the compliance data as at least one of radio frequency signals, optical signals, or electrical signals.

14. The orthodontic compliance monitor method of claim 11, further comprising the step of:

displaying the compliance data.

15. A computerized orthodontic compliance system, comprising:

a sensor that senses when an orthodontic appliance is positioned in the mouth for use;

a processor that processes an output of said sensor and generates compliance data based on a compliance protocol;

a memory that stores the compliance data; and

a computer configured to receive the compliance data from said memory.

16. The system of claim 15, further comprising an interface configured to output the compliance data as at least one of radio frequency signals, optical signals, or electrical signals to said computer.

17. The system of claim 15, wherein said sensor comprises at least one of a temperature sensor, pressure sensor, moisture sensor, light sensor, or pH sensor.

18. The system of claim 15, wherein said processor comprises at least one of a micro controller, microprocessor, application specific integrated circuit, counter, or field programmable gate array.

19. The system of claim 15, further comprising an interface configured to transmit the compliance data as at least one of radio frequency signals, optical signals, or electrical signals.

20. The system of claim 15, further comprising an output device configured to output the compliance data.

26. The computerized orthodontic compliance system of claim 15, wherein the processor is included in a compliance monitor attached to the orthodontic appliance.

21. A non-transitory computer readable medium having computer executable code that executes orthodontic compliance monitor processing comprising:

sensing when an orthodontic appliance is positioned in the mouth for use to generate an output;

processing the output and generating compliance data based on a compliance protocol; and

storing compliance data.

22. The non-transitory computer readable medium according to claim 21 wherein the executable code executes orthodontic compliance monitor processing further comprising:

transmitting the compliance data as at least one of radio frequency signals, optical signals, or electrical signals.

23. The non-transitory computer readable medium according to claim 21 wherein the executable code executes orthodontic compliance monitor processing further comprising displaying the compliance data.

24. An orthodontic compliance monitor, comprising:

means for sensing when an orthodontic appliance is positioned in the mouth for use;

means for processing an output of said sensor means and for generating compliance data based on a compliance protocol; and

means for storing the compliance data.

25. An orthodontic appliance compliance monitor, comprising:

an orthodontic appliance comprising one of an orthodontic brace, a retainer, a mouth guard, a bruxism treatment device, and a nightguard;

means for determining when an orthodontic appliance is positioned in the mouth for use arranged on said orthodontic appliance, wherein said determining means generates an output; and

means for comparing the output with a stored compliance protocol to generate compliance data that indicate whether the data from the compliance sensor meets the requirements of the compliance protocol,

wherein said determining means comprises one of a sensor or reactive chemical.

27. A method of determining whether a user is using an orthodontic appliance, said method comprising the steps of:

sensing using a compliance sensor, when an orthodontic appliance is positioned for use in a user'"'"'s mouth to generate an output;

receiving, by a controller in communication with the orthodontic appliance, data from the compliance sensor;

sending the data received from the compliance sensor to a computer;

displaying the data from the compliance sensor; and

processing the data from the compliance sensor and generating compliance data based on a compliance protocol.

28. The method of claim 27, wherein the step of displaying the data from the compliance sensor comprises displaying the data from the compliance sensor on the computer.

29. The method of claim 27, wherein the step of displaying the data from the compliance sensor comprises displaying the data from the compliance sensor on the appliance.

30. The method of claim 27, further comprising displaying the compliance data.

31. The method of claim 30, wherein the step of displaying the compliance data comprises displaying the compliance data on the appliance.

32. The method of claim 30, wherein the step of displaying the compliance data comprises displaying the compliance data on the computer.

33. The method of claim 27, further comprising storing the compliance data.

34. The method of claim 27, wherein the step of processing the data from the compliance sensor and generating compliance data based on a compliance protocol comprises processing the data from the compliance sensor and generating compliance data by the controller.

35. The method of claim 27, wherein the compliance data indicates whether the data from the compliance sensor meets the requirements of the compliance protocol.

36. The method of claim 27, wherein the compliance protocol specifies an amount of time the orthodontic appliance is to be worn over a period of time.

37. A computerized orthodontic compliance system, comprising:

a computer;

a sensor that senses when an orthodontic appliance is positioned in the mouth of a user for use;

a controller in communication with the orthodontic appliance, wherein the controller receives data output from the compliance sensor and provides the data to the computer through an interface;

a processor that processes data output from said sensor and generates compliance data based on a compliance protocol; and

a memory that stores the compliance data.

38. The computerized orthodontic compliance system of claim 37, wherein said processor is located in said controller.

39. The computerized orthodontic compliance system of claim 37, wherein said computer includes an output device that displays information indicative of whether compliance conditions are being met.

40. The computerized orthodontic compliance system of claim 37, wherein the orthodontic device includes an output device that displays information indicative of whether compliance conditions are being met.

41. The computerized orthodontic compliance system of claim 37, wherein the interface is wireless.

42. The computerized orthodontic compliance system of claim 37, wherein the compliance data indicates whether the data from the compliance sensor meets the requirements of the compliance protocol.

43. The computerized orthodontic compliance system of claim 37, wherein the compliance protocol specifies the amount of time the orthodontic appliance is to be worn over a period of time.