Equipment for mandibular anterior fixation devices

Abstract

Providing equipment for anterior mandibular fixation devices. [Solution] A mandibular anterior fixation device (MSD) comprising an upper splint, a lower splint, and at least one sensor is disclosed, the sensor measuring the patient's biological or biophysical aspects. Methods of using the device are also disclosed. In one embodiment, the sensor measures aspects required by a healthcare professional in a prescription. In one embodiment, the prescription comprises an occlusal initiation position and optionally one or more custom therapeutic features.

Description

Technical Field

[0001] (Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 62 / 947,398, filed Dec. 12, 2019, by KIM et al., entitled "ACCESSORIES FOR A MANDIBLE ADVANCEMENT DEVICE", the entire disclosure of which, including any drawings, is incorporated herein by reference.

[0002] (Field of the Invention) The present invention is within the field of dental devices. In particular, the present invention is within the field of computer-aided design techniques for designing and manufacturing dental devices.

Background Art

[0003] A mandibular advancement device (MAD) has a long residence time (i.e., throughout the time the patient is asleep) inside the patient's mouth. During this time, many physiological and physical changes occur within the patient's body, which affect the effectiveness of the MAD and the patient's health. It would be useful to enable the MAD to respond in real time to the patient's changes in order to provide the most effective mandibular position adjustment for the patient at a given time. In addition, a physician desires to have a history of the patient's physical changes while the MAD is being used to provide a better treatment plan.

Summary of the Invention

Means for Solving the Problems

[0004] A mandibular advancement device (MAD) is disclosed that includes an upper splint, a lower splint, and at least one sensor that measures a biological or biophysical aspect of the patient. A method of using the device is also disclosed. The present invention provides, for example, the following. (Item 1) An anterior mandibular fixation device (MAD) comprising an upper splint, a lower splint, and at least one sensor, wherein the sensor measures biological or biophysical aspects of the patient. (Item 2) The sensor is the device described in item 1, which measures aspects required by healthcare professionals in prescriptions. (Item 3) The aforementioned prescription is the device described in item 2, comprising an occlusal initiation position and optionally one or more custom treatment features. (Item 4) The aforementioned custom therapeutic feature is one of the following: an anterior discruder, a splint option, and a change rate adjustment mechanism, as described in item 3 of the device. (Item 5) The device described in item 1, comprising two or more sensors, all of which are located on one sprint of the MAD (either the upper or lower sprint). (Item 6) The device according to item 1, comprising two or more sensors, wherein the sensors are located on different sprints of the MAD. (Item 7) The device according to item 1, wherein the sensor is a physiological sensor, a physical sensor, a chemical sensor, or a position sensor. (Item 8) The physiological sensor is a device according to item 7, which measures patient data including body temperature, respiratory rate, or heart rate, or any variation in data from one point in time to another. (Item 9) The physical sensor is the device according to item 7, which detects vibrations during breathing, airflow, oxygen concentration of inhaled air, carbon dioxide concentration of exhaled air, atmospheric pressure, air pressure inside the patient's oral cavity, noise, pressure exerted on the MAD by the patient's teeth, or actigraphic data. (Item 10) The chemical sensor is a device according to item 7, which detects salivary pH, salivary glucose concentration, salivary conductivity, stress markers, salivary cortisol, blood oxygen saturation, blood pH, blood glucose level, blood insulin concentration, or inflammation markers. (Item 11) The position sensor is the device described in item 7, which detects a record of the position of the MAD inside the mouth relative to a predetermined reference location. (Item 12) The device described in item 1, wherein the sensor is a component of a sensing block, and the sensing block comprises at least one additional component, the additional component being a rechargeable or replaceable battery, a battery recharging circuit compliant with industry standards, onboard memory, a communication module, an analog-to-digital converter, a control module for activating a stepper motor, and an I / O bus for connecting to external components. (Item 13) The device according to item 1, wherein the sensor comprises a communication component configured for wireless communication with a base station. (Item 14) The aforementioned wireless communication is in the form of Bluetooth®, radio, infrared, or magnetic communication, as described in item 13. [Modes for carrying out the invention]

[0005] A sensor that, when combined with a mandibular anterior fixation device (MAD), can measure certain biological or biophysical aspects of a patient is disclosed herein.

[0006] Certain MADs intended for use in conjunction with the sensors of this disclosure have been described previously. See, for example, USP 9,820,882, USP 9,808,327, U.S. Patent Application Publication 2018 / 0024530, and 2019 / 0105191, International Publication WO2019 / 018309Al, and International Patent Application PCT / US2019 / 029471. All disclosures of the publications listed in this paragraph ("Publications Incorporated Above") are incorporated herein by reference to any drawings, in particular aspects of this disclosure that disclose MADs, methods for designing them, methods for manufacturing them, or fittings for them.

[0007] The MAD and sensor combination disclosed herein offers numerous advantages. The entire device is 100% self-contained, fully fixed and permanently resides inside the patient's mouth, and enables a complete lip seal. The device is custom-manufactured to seamlessly integrate the sensor and device mechanism with patient comfort in mind (by combining patient anatomical data input and healthcare professional (HCP) prescriptions with a manufacturing library of elements).

[0008] In some embodiments, the HCP prescription includes the occlusal initiation position and optionally one or more custom therapeutic features (such as anterior discruders, splint options, change adjustment mechanisms, and other features listed in the publication incorporated above).

[0009] In some embodiments, if the MAD has two or more sensors, the MAD is designed and manufactured so that the sensors are located on one sprint of the MAD (i.e., either the upper or lower sprint). In other embodiments, the sensors are located on different sprints. Throughout this disclosure, sprints with sensors are referred to as “technical sprints,” while sprints without any sensors are referred to as “free sprints.”

[0010] In some embodiments, the splint is designed so that the most critical components (e.g., sensors) are protected. For example, if device failure occurs due to the patient unconsciously grinding, chewing, or biting against the device, the free splint is designed to fail first before the technical splint. This is achieved either by making the free splint thinner than the technical splint, or by making the two splints from different materials. The free splint is easier to remake at a lower cost and is more convenient than the technical splint. (sensor)

[0011] Various sensors are expected to be used in conjunction with the disclosed MAD. Generally, sensors can be divided into the following categories: physiological sensors, physical sensors, chemical sensors, and position sensors.

[0012] In some embodiments, the physiological sensor measures and relays physiological data such as body temperature, respiratory rate, heart rate, or other relevant physiological data, and / or any fluctuations in the above values.

[0013] In some embodiments, the physical sensors are those that detect the mode of respiration (e.g., vibrations in respiration, airflow, oxygen concentration of inhaled air, etc.) and relate it to airflow limitations. In some embodiments, the sensors are selected from oxygen sensors that measure the oxygen concentration of inhaled air, carbon dioxide sensors that measure the carbon dioxide concentration of exhaled air, pressure sensors that measure the air pressure or air pressure inside the oral cavity, airflow sensors, noise detectors, or actigraphy sensors. The sensors may also detect snoring and / or perform airway flow signature analysis. In some embodiments, the sensors measure the pressure exerted on the MAD by the patient's teeth to measure the extent of bruxism and / or friction on the dental arch surface.

[0014] In some embodiments, the chemical sensor is used to measure the physiological response of the body to breathing. For example, levels of stress markers such as salivary pH, salivary sugar concentration, salivary conductivity, salivary cortisol, blood oxygen saturation, blood pH, blood glucose level, blood insulin concentration, inflammatory markers, etc. can be measured in real-time and reported to the HCP via a base station. The bacterial biosensor can provide information to the HCP at the level of bacterial activity in the mouth during sleep.

[0015] In some embodiments, the position sensor is used to record the position of the MAD in the mouth relative to a predetermined reference location. The sensor can optionally track the movement of the mandible in the anterior-posterior, vertical, and / or lateral directions.

[0016] In some embodiments, the sensor is a component of a sensing block, and the sensing block includes other components in addition to the sensor. In one embodiment, the sensing block components include a battery (rechargeable or replaceable), a battery recharge circuit compatible with industry standards, an on-board memory if applicable, a communication module, an analog-to-digital converter for converting the sensor voltage input to a digital signal, a control module for activating the stepping motor, and one or more of an I / O bus for connecting to external sensors and motors.

[0017] In some embodiments, during the design of a MAD having at least one sensor, the sensor and the pocket in which the sensor is installed are design library elements in a computer-aided design (CAD) program. The designer selects the relevant library elements and the location where the sensor is supposed to be installed on the MAD, and the CAD program provides the design accordingly. For discussion of the design of a MAD using library elements, see incorporated herein by reference U.S. Publication No. 2018 / 0024530. (Communication)

[0018] The sensors of the present disclosure communicate wirelessly with a base station and transmit the data they acquire. Various modes of wireless communication are well-known in the art. Currently, the most well-known mode is thought to be Bluetooth® communication. Other modes such as wireless, infrared, magnetic, etc. can also be used. All modes of wireless communication currently known or developed in the future are envisioned for use with the sensors of the present disclosure.

[0019] In some embodiments, the base station is software included in a physical cradle. The cradle is configured for wireless communication using sensors embedded within the MAD. In some embodiments, following use, the patient optionally places the MAD in a cradle that can recharge the sensor's battery. In some embodiments, the cradle is configured to clean the MAD, for example, by providing a receptacle in which the MAD can be placed or by having a chamber that includes wells for the MAD to be cleaned using, for example, a cleaning agent or steam. In other embodiments, the base station is software (including apps) on a smartphone (e.g., iPhone®, Galaxy®), a smart tablet (e.g., iPad®, Surface®), or a laptop or desktop computer (collectively, “devices”).

[0020] In some of the embodiments, the base station records the position of the mandible over time. The HCP can then relate the physiological response at a given time to the mandible position at that time and, as appropriate, determine a course of treatment.

[0021] In some embodiments, the base station and the MAD operate within a feedback system. When data acquired by the sensor communicates with the base station, the base station analyzes the data and relays commands to the MAD to perform actions in response based on a predefined routine. In some embodiments, the predefined routine is based on a prescription by the HCP.

[0022] In some embodiments, the response is a mechanical response. In these embodiments, the MAD includes a stepping motor (for example, embedded in a dorsal configuration) that can advance or retract the mandible symmetrically or asymmetrically in increments of 0.1 mm or any other multiple thereof.

[0023] In some embodiments, the base station would sound a sufficiently audible alarm to wake the patient if physiological data, such as blood oxygen levels or airflow disturbances, indicates an unhealthy condition that would cause the patient to remain asleep. In other embodiments, the base station would relay a command to the MAD to release an unpleasant chemical, such as a bitter substance, into the patient's mouth to wake them.

[0024] In some embodiments, the base station is programmed to alert emergency medical services if physiological data deteriorates and the patient shows no signs of getting up (for example, by turning off the alarm).

[0025] In some embodiments, the MAD and sensor combination of the present disclosure is used to deliver medication to a patient in a controlled manner. In some of these embodiments, the MAD has a built-in refillable cavity that can be filled with prescribed medication. In other embodiments, the MAD has a place for placing a pre-filled container of medication. In either case, the design of the MAD with the medication dispensing component is such that the patient does not perceive the bulkiness of the medication dispensing component, and the MAD is as comfortable to wear as if it did not have a medication dispensing component.

[0026] In response to time queues or inputs from embedded sensors, the base station relays commands to the MAD and drug dispensing components to release a predetermined amount of drug between the cheek and gums for oral administration, or into the patient's mouth for drug inhalation. Examples include stress relievers, sedatives, glucose, insulin, nitroglycerin, or other cardiac medications for atrial fibrillation or unstable angina.

[0027] In some embodiments of the MAD, such as those described in the international patent application PCT / US2019 / 029471 incorporated above, the MAD includes an internal mechanism for advancing the mandible forward, for example, by turning a screw. In some of these embodiments, a small stepping motor is connected to the advancement mechanism. In some embodiments, for example, in response to data obtained from sensors, such as whether the airflow through the mouth is laminar or turbulent, heart rate variability, blood oxygen saturation, etc., the base station sends commands to the MAD stepping motor to advance or retract the mandible by slight augmentation until the situation is corrected, for example, until the airflow becomes laminar, or until the snoring weakens, or until the blood oxygen concentration increases. Biofeedback provided by the sensors allows the base station to control the treatment in real time.

[0028] In some embodiments, the base station communicates wirelessly with software on a device operated by a healthcare professional (HCP). In these embodiments, the base station communicates the collected data directly to the HCP device, allowing the HCP to monitor the patient's progress without the patient having to visit the office. This feature is particularly useful for individuals who are constantly traveling, such as salespeople, long-distance drivers, and airline pilots. By leveraging this feature, the HCP can continuously monitor the patient and intervene as recommended, when it is in the patient's best interest. Thus, problems are detected and corrected as they occur.

[0029] In some embodiments, the base station communicates with the HCP software via the Internet, telephone lines, satellite, radio, microwave, or other forms of long-range communication that are currently known or will be developed in the future.

[0030] In some embodiments, the base station may, according to a predetermined routine, analyze the data and cause the MAD to change the position of the mandible relative to the maxilla in order to maximize effective results during the use of the MAD.

[0031] In some embodiments, multiple sensors are connected to the same sensing block, while in other embodiments, each sensor has its own sensing block.

[0032] When such advancement is required, MADs currently on the market require the patient to turn a screw several times for proper adjustment to advance the mandible. As the screw is turned, the MAD's moving unit moves relative to its stationary unit. In many cases, each adjustment requires turning the screw three or more times. Patient compliance with this instruction is not always 100%, as some patients become distracted and forget how many times they have turned the screw, or the screw is not turned all the way, and other similar issues.

[0033] In some embodiments, the MAD includes a barcode that can be read by a barcode reader such as a smartphone. QR codes (registered trademark), standard barcodes, and other similarly readable diagrams can be used for this purpose. Part of the barcode is printed on the moving unit, and the other half is printed on the stationary unit. At each unit increment, such as 0.1 mm, the two halves of the barcode are aligned to create a code corresponding to the position of the moving unit relative to the stationary unit. If the device is not properly calibrated, the resulting barcode will be garbled and will not receive any information. When the device is properly calibrated, the alignment of the two halves of the barcode corresponds to a code relating to the device's position.

Claims

[Claim 1] Device, method, etc.