US2020337886A1PendingUtilityA1

Systems and methods for providing an automated titration for oral appliance therapy

Assignee: ZST HOLDINGS INCPriority: Mar 31, 2015Filed: Jul 10, 2020Published: Oct 29, 2020
Est. expiryMar 31, 2035(~8.7 yrs left)· nominal 20-yr term from priority
A61F 5/566A61F 5/56A61C 19/04A61C 7/08A61B 5/746A61B 5/7264A61B 5/4818A61B 5/4812A61B 5/4542A61B 5/1116A61B 5/0816G01N 33/48G01N 2800/52
48
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

Systems and methods for performing a multi-test-period titration for oral appliance therapy are described herein. A system includes a mandibular displacement device configured to be positioned in an oral cavity of a subject, a monitoring unit configured to sense one or more physiological inputs from the subject; and a control unit. The system is configured to configure at least one of the mandibular displacement device or the monitoring unit during the diagnostic sleep test protocol, perform the diagnostic sleep test protocol, configure at least one of the mandibular displacement device or the monitoring unit during the titration for oral appliance therapy protocol, and perform the titration for oral appliance therapy protocol.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 . A system for performing a multi-purpose sleep test protocol, comprising:
 a mandibular displacement device configured to be positioned in an oral cavity of a subject;   a monitoring unit configured to sense one or more physiological inputs from the subject; and   a control unit comprising a processing unit and a memory operatively coupled to the processing unit, the memory having computer-executable instructions stored thereon that, when executed by the processing unit, cause the system to:
 configure at least one of the mandibular displacement device or the monitoring unit during the diagnostic sleep test protocol; 
 perform the diagnostic sleep test protocol; 
 configure at least one of the mandibular displacement device or the monitoring unit during the titration for oral appliance therapy protocol; and 
 perform the titration for oral appliance therapy protocol. 
   
     
     
         2 . The system of  claim 1 , wherein the memory has further computer-executable instructions stored thereon that, when executed by the processing unit, cause the system to:
 receive a desired outcome criteria of oral appliance therapy; and   select the diagnostic sleep test protocol or the titration for oral appliance therapy protocol based on the desired outcome criteria.   
     
     
         3 . The system of  claim 1 , wherein the titration for oral appliance therapy protocol is performed in dependence on an outcome of the diagnostic sleep test protocol. 
     
     
         4 . The system of  claim 1 , wherein the memory has further computer-executable instructions stored thereon that, when executed by the processing unit, cause the system to perform the diagnostic sleep test protocol and the titration for oral appliance therapy protocol automatically in succession. 
     
     
         5 . The system of  claim 4 , wherein the diagnostic sleep test protocol and the titration for oral appliance therapy protocol are performed automatically without intervention by a sleep professional. 
     
     
         6 . The system of  claim 1 , wherein the memory has further computer-executable instructions stored thereon that, when executed by the processing unit, cause the system to switch from the diagnostic sleep test protocol to the titration for oral appliance therapy protocol. 
     
     
         7 . The system of  claim 4 , wherein the diagnostic sleep test protocol and the titration for oral appliance therapy protocol are performed in a non-clinical setting. 
     
     
         8 . The system of  claim 3 , wherein the outcome of the diagnostic sleep test protocol is a measure of respiratory events. 
     
     
         9 . The system of  claim 8 , wherein the measure of respiratory events comprises a number, duration, frequency, severity, ratio of apneas or hypopneas, or change in oxygen saturation. 
     
     
         10 . The system of  claim 1 , wherein the diagnostic sleep test protocol and the titration for oral appliance therapy protocol are performed during a single sleep session. 
     
     
         11 . The system of  claim 1 , wherein the diagnostic sleep test protocol and the titration for oral appliance therapy protocol are performed during different sleep sessions. 
     
     
         12 . The system of  claim 11 , wherein the different sleep sessions are on the same night. 
     
     
         13 . The system of  claim 11 , wherein the different sleep sessions are on different nights. 
     
     
         14 . The system of  claim 1 , wherein the memory has further computer-executable instructions stored thereon that, when executed by the processing unit, cause the system to receive diagnostic information concerning the subject. 
     
     
         15 . The system of  claim 14 , wherein the diagnostic information is used to set a parameter for the diagnostic sleep test protocol or the titration for oral appliance therapy protocol. 
     
     
         16 . The system of  claim 14 , wherein the diagnostic information comprises at least one of a baseline measure of respiratory events experienced by the subject, a distribution of respiratory events, a level of desaturation, the subject's body position during a diagnostic sleep study, a sleep stage during a diagnostic sleep study, the subject's physical characteristics, the subject's medical history, or the subject's symptoms. 
     
     
         17 . The system of  claim 1 , wherein performing the diagnostic sleep test protocol comprises:
 monitoring physiological information from the subject; and   analyzing the physiological information to diagnose the subject with a sleep disordered breathing condition.   
     
     
         18 . The system of  claim 17 , wherein the sleep disordered breathing condition is at least one of obstructive sleep apnea (OSA), central sleep apnea (CSA), inspiratory flow limitation (IFL), high upper airway resistance (HUAR), upper airway resistance syndrome (UARS), or snoring. 
     
     
         19 . The system of  claim 1 , wherein performing the titration for oral appliance therapy protocol comprises:
 monitoring physiological information from the subject;   adjusting a protrusion level of the mandibular displacement device; and   analyzing the physiological information to evaluate an outcome of oral appliance therapy.   
     
     
         20 . The system of  claim 19 , wherein the outcome of oral appliance therapy comprises at least one of a prediction of success or failure of oral appliance therapy, a predicted effective protrusion level for oral appliance therapy, or a predicted optimal protrusion level for oral appliance therapy. 
     
     
         21 . The system of  claim 19 , wherein the memory has further computer-executable instructions stored thereon that, when executed by the processing unit, cause the system to receive diagnostic information concerning the subject, wherein the diagnostic information is used to establish the outcome of oral appliance therapy. 
     
     
         22 . The system of  claim 21 , wherein the diagnostic information comprises at least one of a baseline measure of respiratory events experienced by the subject, a distribution of the respiratory events, a level of desaturation, a body position during a diagnostic sleep study, a sleep stage during a diagnostic sleep study, the subject's physical characteristics, the subject's medical history, or the subject's symptoms. 
     
     
         23 . The system of  claim 1 , wherein the memory has further computer-executable instructions stored thereon that, when executed by the processing unit, cause the system to transmit a control signal to the mandibular displacement device. 
     
     
         24 . A method for performing a multi-purpose sleep test protocol, comprising:
 providing a sleep test kit comprising a mandibular displacement device and one or more sensors for measuring physiological information from a subject, wherein the sleep test kit is configured to perform a diagnostic sleep test protocol and a titration for oral appliance therapy protocol;   providing instructions to the subject for configuring the sleep test kit during the diagnostic sleep test protocol;   performing the diagnostic sleep test protocol;   providing instructions to the subject for configuring the sleep test kit during the titration for oral appliance therapy protocol; and   performing the titration for oral appliance therapy protocol.   
     
     
         25 . The method of  claim 24 , wherein the mandibular displacement device is an automatically-controlled mandibular displacement device. 
     
     
         26 . The method of  claim 24 , wherein the titration for oral appliance therapy protocol is performed in dependence on an outcome of the diagnostic sleep test protocol. 
     
     
         27 . The method of  claim 24 , wherein the diagnostic sleep test protocol and the titration for oral appliance therapy protocol are performed automatically in succession. 
     
     
         28 . The method of  claim 24 , wherein the diagnostic sleep test protocol and the titration for oral appliance therapy protocol are performed in a non-clinical setting. 
     
     
         29 . The method of  claim 24 , wherein the outcome of the diagnostic sleep test protocol is a measure of respiratory events. 
     
     
         30 . The method of  claim 29 , wherein the measure of respiratory events comprises a number, duration, frequency, severity, ratio of apneas or hypopneas, or change in oxygen saturation. 
     
     
         31 . The method of  claim 24 , wherein the diagnostic sleep test protocol and the titration for oral appliance therapy protocol are performed during a single sleep session. 
     
     
         32 . The method of  claim 24 , wherein the diagnostic sleep test protocol and the titration for oral appliance therapy protocol are performed during different sleep sessions. 
     
     
         33 . The method of  claim 32 , wherein the different sleep sessions are on the same night. 
     
     
         34 . The method of  claim 32 , wherein the different sleep sessions are on different nights. 
     
     
         35 . The method of  claim 24 , further comprising receiving diagnostic information concerning the subject. 
     
     
         36 . The method of  claim 35 , wherein the diagnostic information is used to set a parameter for the diagnostic sleep test protocol or the titration for oral appliance therapy protocol. 
     
     
         37 . The method of  claim 35 , wherein the diagnostic information comprises at least one of a baseline measure of respiratory events experienced by the subject, a distribution of respiratory events, a level of desaturation, the subject's body position during a diagnostic sleep study, a sleep stage during a diagnostic sleep study, the subject's physical characteristics, the subject's medical history, or the subject's symptoms. 
     
     
         38 . The method of  claim 24 , wherein performing the diagnostic sleep test protocol comprises:
 monitoring physiological information from the subject; and   analyzing the physiological information to diagnose the subject with a sleep disordered breathing condition.   
     
     
         39 . The method of  claim 24 , wherein performing the titration for oral appliance therapy protocol comprises:
 positioning the mandibular displacement device in an oral cavity of the subject;   monitoring physiological information from the subject;   adjusting a protrusion level of the mandibular displacement device; and   analyzing the physiological information to evaluate an outcome of oral appliance therapy.   
     
     
         40 . The method of  claim 39 , wherein the outcome of oral appliance therapy comprises at least one of a prediction of success or failure of oral appliance therapy, a predicted effective protrusion level for oral appliance therapy, or a predicted optimal protrusion level for oral appliance therapy. 
     
     
         41 . The method of  claim 39 , further comprising receive diagnostic information concerning the subject, wherein the diagnostic information is used to establish the outcome of oral appliance therapy. 
     
     
         42 . The method of  claim 24 , further comprising:
 receiving a desired outcome criteria of oral appliance therapy; and   selecting the diagnostic sleep test protocol or the titration for oral appliance therapy protocol based on the desired outcome criteria.   
     
     
         43 . A system for developing a test plan for a multi-purpose sleep test protocol, comprising:
 a mandibular displacement device configured to be positioned in an oral cavity of a subject;   a monitoring unit configured to sense one or more physiological inputs from the subject; and   a control unit comprising a processing unit and a memory operatively coupled to the processing unit, the memory having computer-executable instructions stored thereon that, when executed by the processing unit, cause the system to:
 receive a desired outcome criteria of oral appliance therapy; and 
 select at least one of a diagnostic sleep test protocol or a titration for oral appliance therapy protocol based on the desired outcome criteria. 
   
     
     
         44 . The system of  claim 43 , wherein the memory has further computer-executable instructions stored thereon that, when executed by the processing unit, cause the system to select an oral appliance therapy outcome prediction technique based on the desired outcome. 
     
     
         45 . The system of  claim 43 , wherein the memory has further computer-executable instructions stored thereon that, when executed by the processing unit, cause the system to:
 configure at least one of the mandibular displacement device or the monitoring unit during the diagnostic sleep test protocol;   perform the diagnostic sleep test protocol;   configure at least one of the mandibular displacement device or the monitoring unit during the titration for oral appliance therapy protocol; and   perform the titration for oral appliance therapy protocol.

Join the waitlist — get patent alerts

Track US2020337886A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.