# US 2019/0167467 A1 · Methods and apparatuses for performing remote titration of mandibular protrusion

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- Number: US 2019/0167467 A1
- Document ID: US20190167467A1
- Status: Published application
- Kind: A1
- Application number: 16/266,608
- Filed: 2019-02-04
- Published: 2019-06-06
- Earliest claimed: 2012-06-13
- Assignees: ZST Holdings, Inc.
- Applicants: Zst Holdings, Inc.
- Inventors: John Remmers; Hugo Tam; Terry Macartney; Peter Santosham; Zbigniew Ludwik Topor; Joshua Grosse
- Web page: https://patentgrep.com/patent/US20190167467A1

## CPC

- A61F 5/566: {Intra-oral devices}
- A61B 5/1072: {measuring distances on the body, e.g. measuring length, height or thickness (A61B5/1076 takes precedence)}
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61B 5/4812: {Detecting sleep stages or cycles}
- A61B 5/4818: {Sleep apnoea}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 5/1116: {Determining posture transitions}
- A61B 5/14551: {for measuring blood gases}
- A61B 2560/0228: using calibration standards
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Methods and apparatus for performing system validation and providing predictive criteria during remote titration of mandibular protrusion are disclosed herein. The effectiveness of oral appliance therapy can possibly be improved by screening obstructive sleep apnea subjects and prospectively identifying subjects suitable for oral appliance therapy. The methods and apparatus for performing system validation on an oral appliance therapy titration system are disclosed. In addition, methods and apparatus for providing predictive criteria during remote titration of mandibular protrusion are disclosed. Further, methods and apparatus for display results of remote titration of mandibular protrusion are disclosed.

## Claims

### Claim 1

An oral appliance titration system, comprising:
a mandibular protruder;
a drive motor configured to effect relative displacement of the mandibular protruder; and
a controller comprising a processor and a memory, the memory having computer-executable instructions stored thereon that, when executed by the processor, cause the processor to:
command the mandibular protruder to a plurality of positions;
receive an actual physical position of the mandibular protruder at each of the plurality of commanded positions;
compare the actual physical position to an expected position of the mandibular protruder at each of the plurality of commanded positions; and
detect whether the oral appliance titration system is validly operating based on the comparison.

### Claim 2 (depends on 1)

The oral appliance titration system of claim 1, wherein comparing the actual physical position to an expected position of the mandibular protruder further comprises calculating a deviation between the actual physical position and a detected feedback position of the mandibular protruder for each of the plurality of commanded positions, and wherein detecting whether the oral appliance titration system is operating validly is based on the calculated deviation for each of the plurality of commanded positions.

### Claim 3 (depends on 2)

The oral appliance titration system of claim 2, wherein the detected feedback position is related to calibration data for the drive motor, the calibration data defining a response of the drive motor within a predetermined tolerance.

### Claim 4 (depends on 3)

The oral appliance titration system of claim 3, wherein the response of the drive motor is linear, and wherein the calibration data comprises an n-character string defining the linear response of the drive motor.

### Claim 5 (depends on 3)

The oral appliance titration system of claim 3, wherein the oral appliance titration system is validly operating when the deviation at each of the plurality of commanded positions is within the predetermined tolerance.

### Claim 6 (depends on 5)

The oral appliance titration system of claim 5, wherein the predetermined tolerance is +/−0.5 mm.

### Claim 7 (depends on 2)

The oral appliance titration system of claim 2, wherein the actual physical position of the mandibular protruder is determined using a scale on the mandibular protruder.

### Claim 8 (depends on 2)

The oral appliance titration system of claim 2, wherein the detected feedback position is related to a detected voltage and calibration data for the drive motor.

### Claim 9 (depends on 1)

The oral appliance titration system of claim 1, wherein commanding the mandibular protruder to a plurality of positions further comprises commanding the mandibular protruder to at least three positions.

### Claim 10 (depends on 9)

The oral appliance titration system of claim 9, wherein the at least three positions are a fully retruded position of the mandibular protruder, a fully protruded position of the mandibular protruder and a position between the fully retruded and fully protruded positions.

### Claim 11 (depends on 3)

The oral appliance titration system of claim 3, wherein the deviation at one or more of the plurality of commanded positions is not within the predetermined tolerance, and wherein the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the processor to:
calculate a suggested adjustment for the mandibular protruder;
determine whether the suggested adjustment is within a predetermined range; and
in response to determining that the suggested adjustment is within the predetermined range, adjust an initial position of the mandibular protruder based on the suggested adjustment.

### Claim 12 (depends on 11)

The oral appliance titration system of claim 11, wherein the suggested adjustment comprises an average of the deviations for the plurality of commanded positions.

### Claim 13 (depends on 11)

The oral appliance titration system of claim 11, wherein the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the processor to:
re-command the mandibular protruder to the plurality of commanded positions;
receive an updated actual physical position of the mandibular protruder at each of the plurality of commanded positions;
calculate an updated deviation between the updated actual physical position and an updated detected feedback position of the mandibular protruder for each of the plurality of commanded positions; and
detect whether the oral appliance titration system is validly operating based on the calculated updated deviation for each of the plurality of commanded positions.

### Claim 14 (depends on 13)

The oral appliance titration system of claim 13, wherein the oral appliance titration system is validly operating when the updated deviation at each of the plurality of commanded positions is within the predetermined tolerance.

### Claim 15 (depends on 11)

The oral appliance titration system of claim 11, wherein the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the processor to, in response to determining that the suggested adjustment is not within the predetermined range, recommend replacing the mandibular protruder.

### Claim 16 (depends on 3)

The oral appliance titration system of claim 3, wherein the deviation at one or more of the plurality of commanded positions is not within the predetermined tolerance, and wherein the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the processor to:
calculate a suggested adjustment for the mandibular protruder;
calculate a difference between the deviation at each of the plurality of commanded positions and the suggested adjustment;
determine whether the difference is within a drive motor tolerance range; and
in response to determining that the difference is not within the drive motor tolerance range, recommend replacing the drive motor.

### Claim 17 (depends on 16)

The oral appliance titration system of claim 16, wherein the suggested adjustment comprises an average of the deviations for the plurality of commanded positions.

### Claim 18 (depends on 5)

The oral appliance titration system of claim 5, wherein the oral appliance titration system further includes a polysomnogram, and wherein the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the processor to calibrate a channel of the polysomnogram, wherein calibrating the channel of the polysomnogram further comprises:
receiving an upper limit and a lower limit for the mandibular protruder;
commanding the mandibular protruder to the upper limit and the lower limit;
receiving an actual physical position of the mandibular protruder at each of the upper limit and the lower limit;
calculating a deviation between the actual physical position and a detected feedback position of the mandibular protruder for each of the upper limit and the lower limit; and
determining whether the channel of the polysomnogram is calibrated based on the calculated deviation for each of the upper limit and the lower limit.

### Claim 19 (depends on 18)

The oral appliance titration system of claim 18, wherein the channel of the polysomnogram is calibrated when the deviation at each of the upper limit and the lower limit is within the predetermined tolerance.

### Claim 20 (depends on 19)

The oral appliance titration system of claim 19, wherein the predetermined tolerance is +/−0.5 mm.

### Claim 21 (depends on 19)

The oral appliance titration system of claim 19, wherein the upper limit and the lower limit are patient-specific limits.

### Claim 22 (depends on 21)

The oral appliance titration system of claim 21, wherein the upper limit and the lower limit are related to a fully protruded and a fully retruded position of a patient's jaw.

### Claim 23

A non-transitory computer-readable recording medium for validating operation of an oral appliance titration system including a mandibular protruder having a drive motor, the non-transitory computer-readable recording medium having computer-executable instructions stored thereon that, when executed by a computing device, cause the computing device to:
command the mandibular protruder to a plurality of positions;
receive an actual physical position of the mandibular protruder at each of the plurality of commanded positions;
compare the actual physical position to an expected position of the mandibular protruder at each of the plurality of commanded positions; and
detect whether the oral appliance titration system is validly operating based on the comparison.

### Claim 24 (depends on 23)

The non-transitory computer-readable recording medium of claim 23, wherein comparing the actual physical position to an expected position of the mandibular protruder further comprises calculating a deviation between the actual physical position and a detected feedback position of the mandibular protruder for each of the plurality of commanded positions, and wherein detecting whether the oral appliance titration system is operating validly is based on the calculated deviation for each of the plurality of commanded positions.

### Claim 25 (depends on 24)

The non-transitory computer-readable recording medium of claim 24, wherein the detected feedback position is related to calibration data for the drive motor, the calibration data defining a response of the drive motor within a predetermined tolerance.

### Claim 26 (depends on 25)

The non-transitory computer-readable recording medium of claim 25, wherein the oral appliance titration system is validly operating when the deviation at each of the plurality of commanded positions is within the predetermined tolerance.

### Claim 27 (depends on 24)

The non-transitory computer-readable recording medium of claim 24, wherein the actual physical position of the mandibular protruder is determined using a scale on the mandibular protruder.

### Claim 28

A method for validating operation of an oral appliance titration system including a mandibular protruder having a drive motor, the method comprising:
commanding the mandibular protruder to a plurality of positions;
receiving an actual physical position of the mandibular protruder at each of the plurality of commanded positions;
comparing the actual physical position to an expected position of the mandibular protruder at each of the plurality of commanded positions; and
detecting whether the oral appliance titration system is validly operating based on the comparison.

### Claim 29 (depends on 28)

The method of claim 28, wherein comparing the actual physical position to an expected position of the mandibular protruder further comprises calculating a deviation between the actual physical position and a detected feedback position of the mandibular protruder for each of the plurality of commanded positions, and wherein detecting whether the oral appliance titration system is operating validly is based on the calculated deviation for each of the plurality of commanded positions.

### Claim 30 (depends on 29)

The method of claim 29, wherein the detected feedback position is related to calibration data for the drive motor, the calibration data defining a response of the drive motor within a predetermined tolerance.

### Claim 31 (depends on 30)

The method of claim 30, wherein the oral appliance titration system is validly operating when the deviation at each of the plurality of commanded positions is within the predetermined tolerance.

### Claim 32 (depends on 28)

The method of claim 28, wherein the actual physical position of the mandibular protruder is determined using a scale on the mandibular protruder.
