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WO2024206009A1 - Sensor units for use with a medical implant stability analyzing system, and related systems and methods - Google Patents

Sensor units for use with a medical implant stability analyzing system, and related systems and methods Download PDF

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Publication number
WO2024206009A1
WO2024206009A1 PCT/US2024/020659 US2024020659W WO2024206009A1 WO 2024206009 A1 WO2024206009 A1 WO 2024206009A1 US 2024020659 W US2024020659 W US 2024020659W WO 2024206009 A1 WO2024206009 A1 WO 2024206009A1
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WO
WIPO (PCT)
Prior art keywords
abutment
ring
sensor
attachment portion
arms
Prior art date
Application number
PCT/US2024/020659
Other languages
French (fr)
Inventor
I-Yeu Steve SHEN
Zi YE
Original Assignee
University Of Washington
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by University Of Washington filed Critical University Of Washington
Publication of WO2024206009A1 publication Critical patent/WO2024206009A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1111Detecting tooth mobility
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/45For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4538Evaluating a particular part of the muscoloskeletal system or a particular medical condition
    • A61B5/4542Evaluating the mouth, e.g. the jaw
    • A61B5/4547Evaluating teeth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6814Head
    • A61B5/682Mouth, e.g., oral cavity; tongue; Lips; Teeth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C19/00Dental auxiliary appliances
    • A61C19/04Measuring instruments specially adapted for dentistry

Definitions

  • a sensor unit for use with a medical implant (including a dental implant) stability analyzing system, and related systems and methods.
  • a sensor unit includes a sensor housing, a motor, and a sensor secured to the sensor housing.
  • the sensor housing has an attachment portion configured to detachably secure the sensor housing to an abutment.
  • the motor is secured to the sensor housing and configured to exert a lateral force on the implant.
  • the sensor is configured to measure at least one of vibration or motion of the implant secured responsive to a mechanical force exerted by the motor, and further configured to communicate with a control unit.
  • an implant stability analyzing system includes any one of the sensor units disclosed herein, a control unit, and an electronic device.
  • the control unit is configured to communicate with the sensor unit, direct the motor of the sensor unit to exert a mechanical force and/or a lateral force on the implant, and receive acceleration of the implant measured by the sensor of the sensor unit.
  • the electronic device is configured to communicate with the control unit, receive the acceleration measured by the sensor of the sensor unit, and determine a stability of the implant.
  • a method of securing a sensor unit of a medical implant (including a dental implant) stability analyzing system to an abutment includes providing the sensor unit, comprising a sensor housing having an attachment portion, a motor secured to the sensor housing and configured to exert a lateral force on the implant; and a sensor secured to the sensor housing, the sensor being configured to measure at least one of vibration or motion of the implant secured responsive to the mechanical force exerted by the motor, and configured to communicate with a control unit.
  • the method includes detachably securing the attachment portion of the sensor housing to an abutment.
  • a method of analyzing stability of an implant includes securing a sensor unit to an abutment secured to an implant according to any one of the embodiments disclosed herein.
  • the method includes, with a control unit, selecting a tooth position of the implant, selecting a type of the implant, selecting a type of the abutment, directing a motor of the sensor unit to exert a mechanical and/or lateral force on the implant, receiving acceleration of the implant measure by a sensor of the sensor unit; and determining a stability of the implant using a mechanics-base prediction model.
  • FIG. 1A is a partial cross-sectional side view' of a healing abutment on a dental implant, according to an embodiment.
  • FIG. IB is an exploded view of a crown, an abutment, and a dental implant. according to an embodiment.
  • FIG. 2A is a schematic of a dental implant stability analyzing system, according to an embodiment.
  • FIG. 2B is an exploded view of a sensor unit of a dental implant stability analyzing system, according to an embodiment.
  • FIG. 2C is a bottom isometric view of a sensor unit and an abutment, according to an embodiment.
  • FIG. 3A is a top view of an attachment portion of a sensor unit secured to an abutment, according to an embodiment.
  • FIG. 3B is a top view of an attachment portion of a sensor unit secured to an abutment, according to an embodiment.
  • FIG. 3C is a partial cross-sectional side view of the sensor unit of FIG. 3C secured to an abutment, according to an embodiment.
  • FIG. 3D is a top view of an attachment portion of a sensor unit secured to an abutment, according to an embodiment.
  • FIG. 4A is a partial cross-sectional side view of a sensor unit secured to an abutment, according to an embodiment.
  • FIG. 4B is an isometric side view two arms and wedge of an attachment portion of a sensor unit, according to an embodiment.
  • FIG. 4C is an isometric side view of two arms and a tapered head of a detent element of an attachment portion of a sensor unit, according to an embodiment.
  • FIG. 4D is a partial cross-sectional side view of a sensor unit secured to an abutment, according to an embodiment.
  • FIG. 4E is a partial cross-sectional side view of a sensor unit secured to an abutment, according to an embodiment.
  • FIG. 5A is a partial cross-sectional side view of a sensor unit secured to an abutment, according to an embodiment.
  • FIG. 5B is an isometric bottom view of an attachment portion of the sensor unit of FIG. 5A, according to an embodiment.
  • FIG. 5C is a side view of a sensor unit secured to an abutment, according to an embodiment.
  • FIG. 5D is a side view of a sensor unit secured to an abutment, according to an embodiment.
  • FIG. 6 is a flow diagram of a method of securing a sensor unit to an abutment. according to an embodiment.
  • Embodiments disclosed herein include dental implant stability analyzing devices, sensor units having an attachment element, and related systems and methods of use.
  • the dental implant stability analyzing devices may include electro-mechanical devices that measures stability of a dental implant in bone.
  • a dental implant stability’ analyzer is a device or system to measure the level of osseointegration of an implant.
  • a sensor unit for use with a medical implant (including a dental implant) stability’ analyzing system includes a base having a seating member protruding from the base and configured to secure the sensor unit to an abutment.
  • the senor unit includes a motor secured to the base and configured to exert a lateral force on the implant.
  • the sensor unit further includes a sensor secured to and electrically coupled to the motor, the sensor being configured to measure at least one of vibration or motion of the implant secured responsive to the mechanical force exerted by the motor, and configured to communicate with a control unit.
  • Embodiments of sensor units disclosed herein include a universal coupler, through which a sensor unit can be attached onto a crown or an abutment. While healing abutments are specifically referenced in certain embodiments described herein, the sensor units may be configured to attach any of a number of different dental abutments, such as healing abutments, locator abutments, multi-unit abutments, impression copings, etc. Furthermore, embodiments of the sensor units described herein may be configured to attach to dental healing caps. Since there is no need to remove the abutment or crown, embodiments of the sensor unit are easier, faster, and safer to use with the universal coupler. Moreover, the coupler can attach onto abutments and crowns of arbitrary geometry, allowing the sensor unit to be one-size-fits-all, significantly saving the costs.
  • the universal coupler of a sensor unit includes two or more sections of semi-circular inner surfaces.
  • the two or more sections of semi-circular inner surfaces may be hinged or secured together at one point to allow relative rotation. At the opposite side of the hinge, the two sections may be engaged via a locking mechanism. Therefore, the two or more sections of semi-circular inner surfaces may be configured to lock onto an abutment or a crown. The ability to rotate and lock allows the coupler to adjust itself to accommodate different diameters of the abutment.
  • the two or more semi-circular inner surfaces may include at least an end stop, a side wall, and a taper. When the two or more sections are locked onto an abutment, the surface features form a three-point contact with the abutment, thus accommodating abutments of arbitrary shapes.
  • Dental implant stability refers to immobility of a dental implant in its surrounding bone.
  • High implant stability is an indicator of successful osseointegration, which manifests in strong functional and structural connection between the implant and the bone.
  • Implant stability is a vital sign reflecting the well-being of an implant throughout its life cycle.
  • FIG. 1A is a partial cross-sectional side view of implant healing assembly 100a including a healing abutment 104 on a dental implant 102, according to an embodiment.
  • implant dentistry the standard of care is to place an implant in bone 108 in the gum tissue 106 of a patient.
  • the healing abutment 104 is then attached over the implant 102 to shape the gum tissue 106.
  • FIG. IB is an exploded view of an implant crown assembly 100b including a crown 110, an abutment 112, and the dental implant 102, according to an embodiment. After the bone 108 heals, dentists typically replace the healing abutment 104 with the abutment 112, on which the crown 110 will be attached to receive bite loads.
  • dentists Before placing the crown 1 10, dentists must assure that the implant 102 has enough stability (i.e., pre-crown stability). Otherwise, complications —such as pain, bone loss, or even failure — may occur after the crown 110 is secured to the implant 102. If, for example, a dentist finds low stability of the implant 102 in the bone 108, the dentist may choose to let the bone 108 heal longer or take remedial actions. Even after the crown 110 is successfully placed, a dentist may desire to regularly check the stability of the implant 102 (i.e., postcrown stability). Many dentists, however, rely on subjective measures to evaluate implant stability, such as visual inspection, touch of hands, X-ray images, or torqueing the implant. These subjective measures by the dentist may inaccurately indicate the implant 102 is stable when it is unstable, or inaccurately indicated the implant is unstable when it is stable.
  • Systems and methods described may include an electro-mechanical device that measures pre-crown and post-crown stability of the implant 102 in the bone 108.
  • Systems and method described herein may utilize a model-based measurement tool supported by rigorous mechanical principles.
  • Systems and methods described herein may measure a physical quantity' called “angular stiffness” (unit: N.m) to indicate implant stability'.
  • angular stiffness is the ability of the bone to hold the implant against bending at the junction of the abutment and the implant. Higher bone-implant bonding strength implies higher ability- to withstand bending, thus resulting in higher angular stiffness. Since angular stiffness is a physical quantity, angular stiffness can be measured using a standardized specimen and a standardized operating procedure.
  • angular stiffness measurements can be repeated and verified by anyone and anywhere. Accordingly, angular stiffness measurements can be calibrated, traced, and verified scientifically, independently, and objectively. Angular stiffness is not an artificial nor an empirical index.
  • the devices, assemblies, and methods described herein may be utilized with methods and systems to measure and evaluate stability of medical implants (including dental implants) described and disclosed in U.S. Patent Application No. 16/489,028, the disclosure of which is incorporated herein, in its entirety, by this reference.
  • the devices and assemblies described herein may be utilized with methods and devices to measure angular stiffness of dental and medical implants (including dental implants) described and disclosed in PCT Application No. PCT/US2022/017795. the disclosure of which is incorporated herein, in its entirety, by this reference.
  • FIG. 2A is a schematic of a dental implant stability analyzing system 200, according to an embodiment.
  • the dental implant stability analyzing system 200 may include a sensor unit 202 (e.g. , a disposable sensor unit), a reusable control unit 204, and an application 210 (e.g, module) on an electronic device (e.g., a smartphone or a tablet computer).
  • the sensor unit 202 may be secured to the healing abutment 104 with a quick-connect-fast-release mechanism (e.g., via the embodiments of FIGS. 2B-6D).
  • the sensor unit 202 may be wired or wirelessly (e.g, Wi-Fi or Bluetooth) connected 206 to the control unit 204, and the control unit 204 may be wired or wirelessly connected 208 to the application 210 on the electronic device. In some embodiments, the control unit 204 and the application 210 may be included on a single electronic device.
  • the implant 102 receives a lateral force (e.g. is wiggled and/or vibrated) by a motor 220 (shown in FIG. 2B) of the sensor unit 202, and the motion thereof is sensed to determined stability through the healing abutment 104.
  • the sensor unit 202 When the dental implant stability 7 analyzing system 200 is in use, the sensor unit 202 is first attached onto the healing abutment 104 (for pre-crown stability), according to an embodiment. As provided above, the sensor unit 202 also may alternatively be attached to a locator abutment, a multi-unit abutment, an impression coping, or a healing cap. The sensor unit 202 may then be driven by the motor 220. responsive to instructions from the control unit 204 and/or the application 210 on the electronic device, effective to exert a lateral force on (e.g, wiggle or vibrate) the implant 102 (through the healing abutment).
  • a lateral force on e.g, wiggle or vibrate
  • the sensor 216 e.g., an accelerometer
  • the sensor 216 in the sensor unit 202 may then sense any movement or motion of the implant 102.
  • the measured motion (e.g., in acceleration) of the implant 102 may be converted to stability (e.g., in angular stiffness) through an accurate, mechanics-based model that resides in the application 210 on the electronic device.
  • the mechanics-based model is experimentally validated in benchtop tests before being uploaded into the mobile app, according to an embodiment.
  • the schematic of the dental implant stability analyzing system 200 of FIG. 2A and the operation described above also may apply to post-crown stability measurements, with the exception of the healing abutment 102 shown in FIG.
  • the sensor unit 202 may be attached to the crown 110, rather than the healing abutment 104, for post-crown stability measurements. While pre-crown stability measurements are provided herein to describe the design and functionality of the dental implant stability analyzing system 200, the measurements also may be applied to post-crown stability 7 measurements.
  • FIG. 2B is an exploded view of the sensor unit 202 of the dental implant stability 7 analyzing system 200, according to an embodiment.
  • the sensor unit 202 may include a sensor housing 226, a sensor cover 212, motor 220 (e.g. , a brushless DC (BLDC) motor), a sensor 216 (e.g, an accelerometer, a micro-electro-mechanical system (MEMS) accelerometer, or a g-sensor), a printed circuit board (PCB) 218, and a connector 214 configured to operably connect to the control unit 204.
  • the sensor unit 202 also may include lead wires between the PCB 218 and the connector 214 and between the motor 220 and the PCB 218.
  • the motor 220 may be configured as an electromagnetic motor, a linear resonance actuator, a piezoelectric element, a magnetic element, or another suitable force generating element or actuator.
  • the sensor 216 may result in a single-use, disposable sensor unit 202 or a reusable sensor unit 202 suitable for sterilization via autoclaves.
  • the sensor housing 226 and the sensor cover 212 may be suitable for sterilization (e.g., via an autoclave), while the sensor 216 and the motor 220 are removable from the sensor housing 226 for reuse in a sterile sensor housing [0038]
  • the sensor housing 226 and the sensor cover 212 are made of plastics through injection molding, according to an embodiment.
  • the sensor housing 226 and the sensor cover 212 may include mating steps and flanges (or grooves), such that the sensor cover 212 is configured to close snugly onto the sensor housing 226.
  • the sensor housing 226 may include a first cavity 7 224 (e.g. , a substantially circular cavity) and a second cavity 7 222 (e.g.
  • the motor 220 may include an off-the-shelf haptic motor configured to produce a small and gentle force to wiggle the implant, such as a haptic coin motor.
  • the voltage to operate the motor 220 may be less than 3 volts direct current (DC), and the force produced by the motor 220 may generally be less than about 1 Newton.
  • Displacement of the implant 102 by the motor may be less than 20 pm for low-density bone (15 pound-per-cubic-foot density 7 ).
  • the sensor 216 may be surface mounted onto a rigid or a flexible PCB 218, according to an embodiment.
  • the sensor 216 may include a digital triaxial acceleration sensor mounted on the flexible PCB 218.
  • the sensor 216 may be electrically connected to a pin connector, which may be subsequently connected to the control unit 204.
  • the sensor 216 and the PCB 218 have a small footprint (e.g, about 3 mm by about 3 mm), according to an embodiment.
  • the trace between the sensor 216 and the PCB 218 and the pin connector 214 may be sufficiently long (e.g, at least about 20 cm), so that the pin connector 214 will be situated far outside of the oral cavity of the patient, according to an embodiment.
  • the pin connector 214 may then be electrically connected 206 to the control unit 204 via a long, shielded flex cable. Therefore, the control unit 204 may be remote enough from patents when the dental implant stability analyzing system 200 is in use.
  • the sensor housing 226. the sensor cover 212, the motor 220, and the sensor 216 may be assembled as illustrated in the exploded view of FIG. 2B, according to an embodiment.
  • the motor 200 may be soldered or otherwise coupled to the sensor 216 and the PCB 218 via lead wires. This securement allows the motor 220 to receive power through the lead wires from the control unit 204.
  • the motor 220 may then be assembled or disposed into the first cavity 224 of the sensor housing 226.
  • the first cavity 224 may be designed to be slightly smaller than the diameter of the motor 220.
  • the motor 220 then, may be press-fit into the first cavity 224 of the sensor housing 226.
  • a drop of epoxy or other adhesive is laid between the motor 220 and the base of the first cavity 224 to further secure the motor 220 to the sensor housing 226, according to an embodiment.
  • the sensor 216 and the PCB 218 may then be assembled into the second cavity 222 of the sensor housing 226.
  • the second cavity 222 may be slightly larger than the sensor 216 and the PCB 218 according to an embodiment, so that the sensor 216 and the PCB 218 may be positioned within the second cavity 222 without obstruction.
  • a drop of epoxy or other adhesive may be laid between the PCB 218 and the base of the second cavity 222 to further secure the sensor 216 in place.
  • the sensor housing 226 also may be designed to have the two notches 223, 225 accommodating the lead wires and traces.
  • the sensor cover 212 may then be closed on the sensor housing 226.
  • the seam present between the sensor cover 212 and the sensor housing 226 may be sealed with silicone rubber or other suitable sealant.
  • the notch 223 accommodating traces to the control unit 204 may also be sealed with silicone rubber.
  • the sensor unit 220 With the assembly process, the sensor unit 220 will have adequate package to assure electric insulation as well as waterproofness.
  • the sensor unit may be configured for use as a reusable sensor unit.
  • the sensor housing 226 and the sensor cover 212 may be made of titanium alloy, which is the same material as typically used in many implants and healing abutments.
  • the sensor housing 226 and/or the sensor cover 212 may include one or more of titanium, titanium alloy, aluminum, aluminum alloy, steel, and/or stainless steel. Moreover, the sensor cover 212 and the sensor housing 226 may include slight interference (or mating grooves) so that the sensor cover 212 can close snugly on the sensor housing 226 without falling apart on its own.
  • the motor 220 and the sensor 216 can be encapsulated in resin, for example, as a single and solid unit for electric insulation and waterproofhess. Also, the encapsulated motor 220, PCB 218, and sensor 216 unit may be removable from the sensor housing 226 as one single module.
  • the encapsulated motor 220, PCB 218, and sensor 216 unit may first be placed into the sensor housing 226.
  • the sensor cover 212 may then close snugly onto the sensor housing 226. Any opening of the sensor housing 226 to the oral cavity may be sealed with, for example, petroleumjelly.
  • the sensor unit 202 may be removed from the healing abutment 104.
  • the sensor cover 212 may then be opened, and the encapsulated motor 220, PCB 218, and sensor 216 unit may be removed and chemically disinfected.
  • the titanium sensor cover 212 and sensor housing 226 may be sterilized in autoclaves ready for their next use.
  • the sensor housing 226 has an attachment portion configured to facilitate a fast connection to and an easy release from the healing abutment 104, according to an embodiment.
  • FIG. 2C is a bottom isometric view of the sensor unit 202 and an abutment 104, according to an embodiment.
  • An attachment portion may be disposed on the bottom surface 227 or base of the sensor housing 226.
  • the attachment portion of the sensor unit 202 includes a central shaft 228, a concentric seating ring 230, and a radial release slot 232. These features of the sensor unit 202 may form a universal coupler, according to one embodiment.
  • attachment portion of the sensor unit 202 (as well as other attachment portions disclosed herein) include reference to attachment of the sensor unit 202 to a healing abutment 104, the sensor unit 202 also may alternatively be attached to a locator abutment, a multi-unit abutment, an impression coping, or a healing cap.
  • the seating ring 230 may extend less than about 1 mm from a bottom surface 227 of the sensor housing 226.
  • the seating ring 230 may extend less than about 0.75 mm, less than about 0.5 mm, less than about 0.4 mm, less than about 0.3 mm, less than about 0.25 mm, about 0.2 mm to about 0.8mm, about 0.2 to about 0.7 mm, about 0.2 mm to about 0.6 mm, about 0.2 mm to about 0.5 mm, about 0.2 mm to about 0.4 mm, or about 0.2 mm to about 0.3 mm from the bottom surface 227 of the sensor housing 226.
  • the seating ring 230 may include a radial thickness of about 0. 1 mm to about 0.5 mm, about 0. 1 mm to about 0.3 mm, about 0.1 mm to about 0.2 mm, about 0. 15 mm to about 0.25 mm, or about 0.2 mm to about 0.3 mm.
  • the central shaft 228 may be slightly bigger than the hole 234 of the healing abutment 104, thereby resulting in a slight interference fit or press-fit when inserting the central shaft 228 into the hole 234 of the healing abutment 104.
  • the central shaft 228 may be threadless (e.g. , threads may be absent from the central shaft 228 or the central shaft 228 is not threaded).
  • the central shaft 228 may include a cross-sectional shape generally complementary to the hole in the healing abutment, such as circular, hexagonal, hexalobular, etc.
  • the central shaft 228 may be tapered with a conical contact/outer surface.
  • the healing abutment 104 may be press-fit onto the central shaft 228 on the bottom surface 227 of the sensor housing 226 forming a firm connection.
  • the seating ring 230 includes a diameter that is about 70% to about 90%. about 75% to about 85%, about 70%, about 75%. about 80%, about 85%, or about 90% of a diameter of the abutment 104.
  • the seating ring 230 may be configured to significantly increase the contact area of the sensor housing 226 with the healing abutment 104, thus making the sensor unit 202 more stable as the motor 220 exerts a lateral force on the implant 102.
  • the seating ring 230 is configured to allow the sensor housing 226 to attach onto healing abutments 104 of many shapes. If needed, temporary dental cement or adhesive may be applied around and outside the seating ring 230 to assist attachment of the sensor housing 226 onto the healing abutment 104. For certain teeth (e.g., incisors) locations, the central shaft 228 and the seating ring 230 can be made longer so that the sensor housing 226 is above neighboring teeth to avoid interference.
  • the radial release slot 232 may be positioned for a dental professional to release the sensor housing 226 from the healing abutment 104.
  • a dental professional may insert the tip of a dental hand tool in the release slot 232, and pry the sensor housing 226 (and thus the sensor unit 202) out of the healing abutment 104.
  • the dental implant stability analyzing system 200 may include the control unit 204 (main body) and a shielded flex cable 206 (accessory) connecting the control unit 204 to the sensor 216 via the connector 214.
  • the control unit 204 may be battery-powered and include an on-off switch that activates and deactivates the control unit 204.
  • the control unit 204 may include a digital display that shows the voltage driving the motor 220 and error messages (when an error occurs).
  • the control unit 204 may include a control knob that activates and deactivates the display and adjusts the voltage to the motor 220, according to an embodiment.
  • the control unit 204 may include a microprocessor. Upon receiving instructions from the application 210 on the electronic device, the microprocessor instructs the sensor unit 202 to exert a lateral force on the implant 102, receives the measured acceleration from the sensor unit 202, and transmits the measured data to the application 210.
  • the function of the application 210 on the electronic device is (a) to command the control unit 204 and the sensor unit 202 to conduct measurements and (b) to extract stability from the measured data.
  • application 210 on the electronic device uses Bluetooth® to communicate with the control unit 204.
  • the application 210 is integrated or embedded in the control unit 204 (e.g, a single electronic device may include both the control unit 204 and the application 210).
  • the application 210 on the electronic device may be configured to allow a dental professional or other use to select a tooth position, select an implant type, select a type of abutment or cap, instruct the motor 220 to exert a lateral force on the implant 102, utilize a mechanics-based prediction model, and output measure stability of the implant.
  • the application 210 includes a user interface (UI) module.
  • the UI may be configured to allow users to remote-control the dental implant stability analyzing system 200 hardware to perform stability measurements.
  • the UI also may be configured to receive the measurement data and displays the final results, such as implant stability.
  • the front end of the UI module may be configured to receive input. Users may select a tooth location (e.g...
  • tooth number 1-32 from a tooth chart, reflecting the exact location of the implant whose stability is to be measured. Users may then select the implant used — such as brand, type, diameter, and length — through dropdown menus. Finally, users may select the healing abutment used — again the brand, type, diameter, and length. These input parameters will be stored for a data processing unit of at least one of the application 210 or the control unit 204.
  • the UI may be configured to allow users to activate the stability measurements.
  • an execution module of at least one of the application 210 or the control unit 204 may activate the control unit and the sensor unit via Bluetooth.
  • the execution module may transfer the measured data from the control unit back to the mobile app via Bluetooth. Both the input parameters and the measured data may be forw arded to the data processing module to extract the stability.
  • the back end of the UI may be configured to present the extracted stability to users in the form of angular stiffness (unit: N.m).
  • the presentation may be numerical and/or graphical, according to an embodiment.
  • the UI may also inform users how the extracted angular stiffness should be interpreted. For example, dentists generally obtain a feel of implant stability through insertion torques, implant stability quotient (IS Q), and drilling artificial bone of various densities.
  • the UI may present the extracted angular stiffness in conjunction with equivalent insertion torque, ISQ, and artificial bone density. Based on the measured angular stiffness and its interpretation, dentists can make a better diagnosis of implant stability.
  • At least one of the control unit 204 or the application 210 may include a data processing module.
  • the data processing module may include a mechanics -based prediction model, according to an embodiment. After the processing module receives the input parameters from the front-end UI as well as the measured data from the execution module, the data processing module may then use the mechanics-based prediction model to extract the angular stiffness to indicate stability based on the input parameters and the measured data.
  • the system 200 may adopt angular stiffness to indicate dental implant stability, an accurate mechanics-based model to allow prediction and extraction of angular stiffness, and benchtop calibration and validation to ensure accuracy of the mechanics-based model. More details regarding the adoption of angular stiffness to indicate dental implant stability', an accurate mechanics-based model to allow prediction and extraction of angular stiffness, and benchtop calibration and validation to ensure accuracy of the mechanics-based model are described and disclosed in U.S. Patent Application No. 16/489,028 and PCT Application No. PCT/US2022/017795, the disclosures of each which are incorporated herein, in their entirety, by this reference. Dental implant stability analyzing systems described herein may then be used to measure the angular stiffness and compared with the calibration.
  • Embodiments of the sensor units disclosed herein may include various configurations and structures of an attachment portion of the sensor housing that allow the sensor housing to be selectively attached to a cap or abutment.
  • FIGS. 3A-5D are various views of attachment portions of various embodiments of sensor housings and sensor units configured to attach to the cap or abutment. Unless otherwise noted, sensor housings including the attachment portions shown in FIGS.
  • the attachment portions shown in FIGS. 3A-5D may include any aspect of the sensor housing shown and described above in relation to FIGS. 2A-2C.
  • the attachment portions shown in FIGS. 3A-5D replace the seating ring 230 and/or the central shaft 228 of the sensor unit 202.
  • the attachment portion of the sensor housing may be configured for a central attachment to the cap or abutment, an outer (or perimeter) attachment to the cap or abutment, or a hybrid combination of central and outer attachments to the cap or abutment.
  • FIG. 3A is a top view of an attachment portion 300a of a sensor unit secured to an abutment 104 (e.g., cap), according to an embodiment.
  • an abutment 104 e.g., cap
  • the upper portion of the sensor housing 226 is removed to allow viewing of the attachment portion 300a of the sensor housing 226, according to an embodiment.
  • the attachment portion 300a of FIG. 3A utilizes or is configured to secure to an outer periphery of the abutment 104. The attachment portion 300a, then, may not secure to the hole 234 of the abutment 104, according to an embodiment.
  • the attachment portion 300a of the sensor housing 226 includes a ring 330a that is oval and/or asymmetric and a determent element, such as a set screw 332a, pin, biasing element (e.g., a compression spring), or other detent secured or securable to the ring 330a.
  • a determent element such as a set screw 332a, pin, biasing element (e.g., a compression spring), or other detent secured or securable to the ring 330a.
  • the ring 330a shown in FIG. 3A may replace the seating ring 230 of the sensor unit 202, and the shaft 228 and/or the release slot 232 of the sensor housing 226 may be absent from the sensor housing used with the attachment portion 300a shown in FIG. 3A.
  • the ring 330a is positioned on a base secured to the sensor housing and/or includes a greater diameter or width than the sensor housing (rather than the smaller diameter of seating ring 230 relative to the sensor housing 226 of the sensor unit 202 in FIG. 2C.
  • the ring 330a may extend from the bottom surface 227 away from the cover 212 to any distance described above in relation to the seating ring 230.
  • the ring 330a that is oval and/or asymmetric may extend from the bottom surface 227 and defines an opening 331a sized to receive a top portion of the abutment 104 therein.
  • the opening 331a may include a first region 331a’ with a smaller radius and a second region 331a” with a larger radius relative to the smaller radius of the first region.
  • larger radius of the second region 331a may include a radius that is about 1.5 times, about 2 times, about 2.5 times, or about 1.5 times to about 2.5 times greater than the smaller radius of the first region 331a'.
  • the smaller radius of the first region 331a’ may be about 1.5 mm and the larger radius of the second region 331 ” may be about 3 mm. Accordingly, in some embodiments, the smaller radius of the first region 331a’ is less than a radius of the abutment 104 and the larger radius of the second region 331a” is greater than a radius of the abutment 104.
  • the second region 331a” may be generally opposite to the first region 331a’ of the opening 331a.
  • This configuration of the opening 331a in the ring 330 allows the top portion of the abutment 104 to be inserted into the opening.
  • the sensor housing 226 may then be moved or adjusted to position the abutment 104 at least proximate to the first region 331a’ of the opening 331a having the smaller radius.
  • This oval and/or asymmetric configuration of the opening 331a in the ring 330 creates at least two contact points 336 between the ring 330 and the abutment 104 at the first region 331a’ of the opening 331a.
  • the set screw 332a may be threadedly secured or securable to the ring 330 proximate to the second region 33 la” of the opening 331a including the larger radius.
  • the set screw 332a is selectively adjustable and, when the top portion of the abutment 104 is positioned within the opening 331a of the ring 330a, the set screw 332a may be rotated to extend the set screw 332a further into the opening 331a. As the set screw 332a is extended further into the opening 331a, the set screw 332a may contact the abutment 104 and create a third contact point 336 on the abutment 104 (in addition to the two contact points 336 between the abutment 104 and the ring 330). The set screw 332a may then be adjusted to tighten the abutment 104 between the three contact points 336, thereby securing the abutment to the attachment portion 300a and the sensor housing 226.
  • This configuration of the attachment portion 300a allows a single sensor housing 226 to be attached to various sizes of abutments 104 and still provide the described three-point contact 336.
  • gum tissue 106 may be around at least a portion of the abutment 104 or may extend closer to the top of the abutment 104 than other regions around the abutment 104.
  • the attachment portion 300a may be positioned such that the set screw 332a is aligned with the side of the abutment 104 having gum tissue 106 extending closer to the top of the abutment 104.
  • the set screw 332a may more easily contact the abutment 104 without contacting the gum tissue 106 than the ring 330 at the first region 331a’ of the opening 33 la having the smaller radius.
  • FIG. 3B is a top view of an attachment portion 300b of a sensor unit 302b secured to an abutment 104 with the sensor housing removed for viewing of the attachment portion 300b
  • FIG. 3C is a partial cross-sectional side view of the sensor unit 302b of FIG. 3C secured to an abutment, according to an embodiment.
  • the sensor unit 302b includes a lower portion 326c of the sensor housing and an upper portion 312c encapsulating the sensor 216 and the motor 220.
  • the upper portion 312c may include a smaller diameter or width than the lower portion 326c of the sensor housing of the sensor unit 302b.
  • the sensor unit 302b may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212.
  • the attachment portion 300b may utilize or be configured to attach to an outer periphery of the abutment 104.
  • the attachment portion 300b of the sensor unit 302b includes a partial or segmented ring 330b, 330c that is at least partially oval and/or asymmetric and a detent element such as a set screw 332b, pin, or other detent secured or securable to the segmented ring 330b, 330c.
  • the segmented ring 330b. 330c may replace the ring 230 of the sensor unit 202, and the shaft 228 and/or the release slot 232 of the sensor unit 202 may be absent from the sensor housing of the sensor unit 302b used with the attachment portion 300b.
  • the segmented ring 330b, 330c is positioned on the lower portion 326c of the sensor housing and/or includes a greater diameter or overall dimension than the upper portion 312c.
  • the segmented ring 330b, 330c may extend from the bottom surface of the lower portion 326c of the sensor housing away from the upper portion 312c to any distance described above in relation to the seating ring 230.
  • the segmented ring 330b. 330c that is oval and/or asymmetric may include at least a first segment 330c and a second segment 330b defining a gap 33 lb or space between the first segment 330c and the second segment 330b.
  • the first segment 330c may be arced at a smaller radius and the second segment 330b may be arced with a larger radius relative to the smaller radius of the first segment 330c.
  • the second segment 330b may be generally opposite to the first segment 330c.
  • This configuration of the gap 331b between the segments of the segmented ring 330b, 330c allows the top portion of the abutment 104 to be inserted into the gap 331b between the first segment 330c and the second segment 330b.
  • the bottom portion 326c of the sensor housing may then be moved or adjusted to position the abutment 104 at least proximate to the first segment 330c having the arc with the smaller radius.
  • This oval and/or asymmetric configuration of the segmented ring 330b, 330c creates at least two contact points 336 between the first segment 330c and the abutment 104.
  • the set screw 332b may be threadedly secured or securable to the second segment 330b that includes the arc having the larger radius.
  • the set screw 332b is selectively adjustable and, when the top portion of the abutment 104 is positioned between the first segment 330c and the second segment 330b, the set screw 332b may be rotated to extend the set screw 332b further into the gap 331b between the first segment 330c and the second segment 330b.
  • the set screw 332b may contact the abutment 104 and create a third contact point 336 on the abutment 104 (in addition to the two contact points 336 between the abutment 104 and the first segment 330c).
  • the set screw 332b may then be adjusted to tighten the abutment 104 between the three contact points 336, thereby securing the abutment 104 to the attachment portion 300b and the sensor unit
  • This configuration of the attachment portion 300b allows a single sensor unit 302b to be attached to various sizes of abutments 104 and still provide the described three- point 336 contact.
  • gum tissue 106 may be around at least a portion of the abutment 104 or may extend closer to the top of the abutment 104 than other regions around the abutment 104.
  • the attachment portion 300b may be positioned such that the set screw 332b is aligned with the side of the abutment 104 having gum tissue 106 extending closer to the top of the abutment 104. As the set screw 332b has less surface area and is more easily aimed, the set screw 332b may more easily contact the abutment 104 without contacting the gum tissue 106 than the first segment 330c having the smaller radius.
  • FIG. 3D is a top view of an attachment portion 300d of a sensor unit secured to an abutment 104 with the sensor housing removed to allow viewing of the attachment portion 300d and the abutment 104, according to an embodiment.
  • the attachment portion 300d may include any aspect of the attachment portion 300b.
  • the attachment portion 300d includes the partial or segmented ring 330b, 330c that is oval and/or asymmetric and an inwardly biased plunger 332d secured or securable to the second segmented ring 330b rather than the set screw 332b of the attachment portion 300d.
  • the inwardly biased plunger 332d may be secured or securable to the second segment 330b that includes the arc having the larger radius.
  • the biased plunger 332d may include a shaft secured to the second segment 330b and a head having a larger diameter or width than the shaft.
  • a biasing element 333d such as a coiled compression spring or resilient material (e.g., rubber), may be disposed between the head of the plunger 332d and the concave inner surface of the second segment 330b.
  • Other embodiments may include various biasing elements.
  • the shaft extends through the second segment 330b such that the shaft may slide through the second segment 330b as a force is applied to the head of the plunger 332d to counteract the biasing element 333d.
  • the plunger 332d includes a grip or attachment region (not shown) generally opposite to the head. The grip or attachment region may include a diameter or width larger than the shaft and/or a hole in the second segment 330b through which the shaft extends.
  • the head may contact the abutment 104 and create a third contact point 336 on the abutment 104 (in addition to the two contact points 336 between the abutment 104 and the first segment 330c).
  • the biasing element 333d may tighten the abutment 104 between the three contact points 336. thereby securing the abutment 104 to the attachment portion 300d and the sensor housing.
  • attachment portion 300d allows a single sensor unit to be attached to various sizes of abutments 104 and still provide the described three-point
  • gum tissue 106 may be around at least a portion of the abutment 104 or may extend closer to the top of the abutment 104 than other regions around the abutment 104.
  • the attachment portion 300d may be positioned such that the plunger 332d is aligned with the side of the abutment 104 having gum tissue 106 extending closer to the top of the abutment 104. As the plunger 332d has less surface area and is more easily aimed, the plunger 332d may more easily contact the abutment 104 without contacting the gum tissue 106 than the first segment 330c having the smaller radius.
  • FIG. 4A is a partial cross-sectional side view of a sensor unit 402a having an attachment portion 400a secured to an abutment 104, according to an embodiment.
  • the sensor unit 402a includes a lower portion 426a of the sensor housing and an upper portion 412a encapsulating the sensor 216 and the motor 220.
  • the upper portion 412a may include a smaller diameter or width than the lower portion 426a of the sensor housing of the sensor unit 402a.
  • the sensor unit 402a may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212.
  • the attachment portion 400a may utilize the hole 234 in the abutment 104 to attach the sensor unit 402a to the abutment 104.
  • the attachment portion 402a of the sensor housing includes a complete or segmented outer ring 430a, two flexible arms 442a, 444a, and a determent element such as a set screw 432a extending through the outer ring 430a to contact at least one arm of the two arms 442a, 444a.
  • the ring 430a, the two flexible arms 442a, 444a, and the set screw 432a may replace the ring 230 of the sensor unit 202, and the shaft 228 and/or the release slot 232 of the sensor unit 202 may be absent from the lower portion 426a of the sensor housing used with the attachment portion 400a.
  • the ring 430a may extend from the bottom surface 427 of the lower portion 426a of the sensor housing to any distance described above in relation to the seating ring 230.
  • the outer ring 430a (whether complete or segmented) may be sized to rest on top of the abutment 104 rather than receive the top portion of the abutment 104 within the ring 430a.
  • the two flexible arms 442a. 444a extend further from the bottom surface 427 than the ring 430a such that the two flexible arms 442a, 444a may extend at least partially into the hole 234 while the ring 430a sits atop the abutment 104.
  • the two flexible arms 442a, 444a may be positioned or spaced such that the two arms 442a. 444a do not fit within the hole 234 (e.g., opening) of the abutment 104 unless compressed and/or pressed closer together. In some embodiments, at least one of the arms 442a, 444a is biased outward towards the outer ring 430a.
  • the set screw 432a may be threadedly secured or securable to the outer ring 430a.
  • the set screw 432a is selectively adjustable and, when the outer ring 430a is positioned on the top portion of the abutment 104, may be rotated to extend the set screw 432a further into the opening 431a of the outer ring 430a to contact a first arm 444a of the two arms 442a, 444a.
  • the set screw 432a may compress the two arms 442a.
  • the set screw 7 432a may press an outwardly biased arm of the two arms 442a, 444a inward until at least some of each of the two arms 442a. 444a fit within the hole 234 in the abutment 104.
  • the set screw 432a may be partially withdrawn from the opening 431a of the outer ring 430a by rotating the set screw 7 432a in an opposite direction to the rotation that extends the set screw 432a further into the opening 431 a of the outer ring 430a.
  • Partially withdrawing the set screw 432a may at least partially release the force exerted by the set screw 7 432a on at least the first arm 444a of the two arms 442a, 444a, thereby allowing the terminating end regions of the tw o arms 442a, 444a disposed in the hole 234 to spread further apart or expand in the hole 234.
  • This spreading apart or expansion of the two arms 442a, 444a in the hole 234 causes the two arms 442a, 444a to contact portions of the abutment 104 defining the hole 234, thereby securing the two arms 442a, 444a partially in the hole 234, and securing the sensor housing to the abutment 104.
  • the hole 234 in the abutment may include a starshaped hole, and each of the two arms 442a, 444a may be secured within a different point of the star to more effectively secure the two arms 442a, 444a to the abutment 104.
  • FIG. 4B is an isometric side view of two arms 442b, 444b and a wedge 432b of an attachment portion 400b of a sensor unit, according to an embodiment.
  • the attachment portion 400b may include any aspect of the attachment portion 400a.
  • the attachment portion 400b may include the wedge 432b extending through the outer ring 430a to contact and/or extend between the two arms 442b, 444b.
  • the ring 430a, the two arms 442b, 444b, and the wedge 432b of the attachment portion 400b may replace the ring 230 of the sensor unit 202, and the shaft 228 and/or the release slot 232 of the sensor unit 202 may be absent from the sensor housing used with the attachment portion 400b.
  • the wedge 432b may be secured or inserted through the outer ring 430a.
  • the wedge may be selectively movable and include a narrow distal end (e g., tip) sized to fit between the two arms 442b, 444b.
  • the wedge 432b As the wedge 432b is pushed inward, the wedge spreads the two arms 442b, 444b further apart.
  • the two arms 442b, 444b may be partially positioned within the hole 234 in the abutment and the wedge 432b may be used to secure the two arms 442b, 444b, and the sensor housing, to the abutment 104.
  • the two arms 442b. 444b may be inserted into the hole 234 of the abutment 104.
  • the wedge 432b may be pushed inward.
  • the wedge 432b forces the two arms 442b, 444b outward, away from one another.
  • the wedge 432b may be pushed until the two arms 442b, 444b are spaced apart in the hole 234 and contacting portions of the abutment 104 defining the hole 234 sufficient to secure the two arms 442b, 444b and the sensor housing to the abutment 104.
  • the attachment portion 400b may include a lock configured to hold the wedge 432b in this position that spreads the arms 442b, 444b apart sufficient to secure the arms 442b, 444b to the abutment 104.
  • the hole 234 in the abutment 104 may include a star-shaped hole, and each of the two arms 442b, 444b may be secured within a different point of the star to more effectively secure the two arms 442b, 444b to the abutment 104.
  • FIG. 4C is an isometric side view of two arms 442c, 444c and a tapered head 433c of a detent element such as a set screw 432c of an attachment portion 400c of a sensor unit, according to an embodiment.
  • the attachment portion 400c may include any aspect of the attachment portion 400a or 400b.
  • the attachment portion 400c may include the set screw 432c having the tapered head 433c extending through the outer ring 430a to contact and/or extend between the two arms 442c, 444c.
  • the ring 430a, the two arms 442c, 444c, and the set screw 432c having the tapered head 433c of the attachment portion 400c may replace the ring 230 of the sensor unit 202. and the shaft 228 and/or the release slot 232 of the sensor unit 202 may be absent from the sensor housing used with the attachment portion 400c.
  • the set screw 432c may be threadedly secured or securable to the outer ring 430a.
  • the set screw 432c may be selectively adjustable and, when the outer ring 430a is positioned on the top portion of the abutment 104, may be rotated to extend the set screw 432a further into the opening 431a of the outer ring 430a to drive the tapered end 433c between the two arms 442c, 444c. As the set screw 432c is extended further into the opening 431c of the ring 430c while betw een the tw o arms 442c, 444c.
  • the set screw 432c may spread apart the two arms 442c, 444c until at least a portion of the two arms 442c, 444c contact portions of the abutment 104 defining the hole 234 in the abutment 104.
  • the set screw 432c may press the two arms 442c, 444c further apart until at least a portion (e.g, the terminating end region) of each of the two arms 442c, 444c fit within the different points of a star-shaped hole in the abutment 104.
  • This expansion or separation of the two arms 442c, 444c in the hole 234 causes the two arms 442c, 444c to contact portions of the abutment 104 defining the hole 234 (e.g., points of the star in a star-shaped hole), thereby securing the two arms 442c, 444c in the hole 234, and securing the sensor housing to the abutment 104.
  • FIG. 4D is a partial cross-sectional side view of an attachment portion 400d of a sensor unit 402d secured to an abutment 104, according to an embodiment.
  • the sensor unit 402d includes a lower portion 426d of the sensor housing and an upper portion 412d encapsulating the sensor 216 and the motor 220.
  • the upper portion 412d may include a smaller diameter or width than the lower portion 426d of the sensor housing of the sensor unit 402d.
  • the sensor unit 402d may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212.
  • the attachment portion 400d may utilize a combination of a central attachment and an outer attachment to the abutment 104.
  • the attachment portion 400d of the sensor housing includes a complete or segmented outer ring, an arm or shaft 444d, and a detent element such as a set screw 432d extending through the a second region 430d of the complete or segmented outer ring to contact the shaft 444d.
  • the ring, the shaft 444d, and the set screw 432d may replace the ring 230, the shaft 228, and/or the release slot 232 of the sensor unit 202.
  • the outer ring may include a first region 430d’ configured to position around a portion of the periphery of the abutment 104 and the second region 430d configured to position on top of the abutment 104.
  • the shaft 444d may be positioned to extend into the hole 234 of the abutment 104 when the first region 430d’ is disposed around the portion of the periphery' of the abutment 104 and the second region 430d is disposed on top of the abutment 104.
  • the second region 430d of the ring may extend from the bottom surface 427d of the lower portion 426d of the sensor housing to any distance described above in relation to the seating ring 230.
  • the first region 430d‘ and the shaft 444d extend further from the bottom surface 427 than the first region 430d of the ring such that the shaft 444d may- extend at least partially into the hole 234.
  • the first region 430d’ of the ring may extend around a periphery of the abutment 104 while the second region 430d of the ring sits atop the abutment 104.
  • the set screw 432d may be threadedly secured or securable to the second region 430d of the ring that is positioned to be disposed on top of the abutment 104.
  • the set screw 432d is selectively adjustable and. when the shaft 444d is disposed within the hole 234 of the abutment 104, the set screw 432d may be rotated to extend the set screw 432d further against the shaft 444d. As the set screw 432d is extended further against the shaft 444d, the set screw 432d may force the shaft 444 and the first region 430d’ of the outer ring closer together to clamp a portion of the abutment 104 therebetween. The set screw 432d may then be adjusted to tighten the abutment 104 between the shaft 444d and the first region 430d’ of the outer ring, thereby securing the abutment 104 to the attachment portion 400d and the sensor housing.
  • FIG. 4E is a partial cross-sectional side view of an attachment portion 400e of a sensor unit 402e secured to an abutment 104.
  • the sensor unit 402e includes a lower portion 426e of the sensor housing and an upper portion 412e encapsulating the sensor 216 and the motor 220.
  • the upper portion 412e may include a smaller diameter or width than the lower portion 426e of the sensor housing of the sensor unit 402e.
  • the sensor unit 402e may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212.
  • the attachment portion 400e may utilize a central attachment to the abutment 104.
  • the attachment portion 400e includes a complete or segmented outer ring 43 Oe, two arms 442e, 444e within the ring 43 Oe, and a detent element such as a set screw 432e extending through the outer ring 430e to contact a first arm 444e of the two arms 442e. 444e.
  • the ring 430e, the two arms 442e, 444e, and the set screw 432e may replace the ring 230, the shaft 228, and/or the release slot 232 of the sensor unit 202.
  • the outer ring 430e (whether complete or segmented) may be sized to rest on top of the abutment 104 rather than receive the top portion of the abutment 104 within the ring 43 Oe.
  • the two arms 442e, 444e may be flexible and positioned or spaced such that the two arms 442e, 444e fit within the hole of the abutment unless spread apart by the set screw 432e.
  • the set screw 432e may extend through the outer ring 430e, and may be threadedly secured or securable through a first arm 444e.
  • the set screw 432e is selectively adjustable and. when the outer ring 430e is positioned on the top portion of the abutment 104, the set screw 432e may be rotated a first direction to spread the two arms 442e, 444e apart and/or rotated a second direction to bring the two arms 442e, 444e closer together.
  • the set screw 432e may be rotated to spread the two arms 442e, 444e further apart, thereby allowing the portions of the two arms 442e, 444e disposed in the hole 234 to expand or spread apart in the hole 234.
  • This spreading apart or expansion in the hole 234 causes the two arms 442e, 444e to contact portions of the abutment defining the hole 234, thereby securing the two arms 442e, 444e in the hole 234, and securing the sensor unit 402e to the abutment 104.
  • the hole 234 in the abutment 104 may include a starshaped hole, and each of the two arms 442e, 444e may be secured within a different point of the star to more effectively secure the two arms 442e, 444e to the abutment 104.
  • FIG. 5A is a partial cross-sectional side view of an attachment portion 500a of a sensor unit 502a secured to an abutment 104
  • FIG. 5B is an isometric bottom view of the attachment portion 500a of the sensor unit 502a of FIG. 5A, according to an embodiment.
  • the sensor unit 502a includes a lower portion 526a of the sensor housing and an upper portion 512a encapsulating the sensor 216 and the motor 220.
  • the upper portion 512a may include a smaller diameter or width than the lower portion 526a of the sensor housing of the sensor unit 502a.
  • the sensor unit 502a may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212.
  • the attachment portion 500a may include a plurality of tabs or clips 530a extending from the bottom surface 527 of the lower portion 526a of the sensor housing.
  • the plurality of clips 530a may extend from the bottom surface 527 any distance provided above in relation to the seating ring 230.
  • the plurality of clips 530a may include two, three, four, or more pins positioned substantially equal distance around an axis a.
  • the plurality of clips 530a may include a flexible and/or resilient material.
  • the plurality of clips 530 and/or the lower portion 526a of the sensor housing may include a plastic material.
  • the plurality of clips 530a may be positioned to form a segmented ring 531 around the axis a having a diameter di.
  • the diameter di of the segment ring 531 including the plurality of clips 530a is less than a diameter d2 of the upper region of the abutment 204, according to an embodiment. Accordingly, when the attachment portion 500a is positioned on the abutment 204, the plurality of clips 530a may form an interference or press fit with the upper region of the abutment 104 effective to attach the attachment portion 500a and the sensor unit 502a to the abutment 104.
  • the attachment portion 500a also may include a positioning shaft or pin 544 extending from the bottom surface 527 of the lower portion 526 of the sensor housing.
  • the pin 544 may be positioned on the axis a to align with the hole 234 of the abutment 104 when the attachment portion 500a is secured to the abutment 104 (e.g, the pin 544 may be central or axially positioned relative to the plurality of clips 530a).
  • the pin 544 may extend a shorter distance from the bottom surface 527 than the plurality of clips 530a.
  • FIG. 5C is a side view of a sensor unit 502c having an attachment portion 500c secured to the abutment 104, according to an embodiment.
  • the sensor unit 502c includes a lower portion 526c of the sensor housing and the upper portion 512a encapsulating the sensor 216 and the motor 220.
  • the sensor unit 502c may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212.
  • the attachment portion 500c may include any aspect of the attachment portion 500a.
  • the attachment portion 500c may include a plurality of clips 530c.
  • the plurality of clips 530c are compliant and/or angle inwards towards the axis a as the plurality of clips 530c extend from the bottom surface 527. In some embodiments, the plurality of clips 530c may taper as the plurality of clips 530c extend from the bottom surface 527. The tapering of the plurality of clips 530c allows the attachment portion 500c to attach to multiple sizes of abutments 104 (e.g., abutments 104 having a variety of diameters).
  • FIG. 5D is a side view of a sensor unit having an attachment portion 500d secured to the abutment 104, according to an embodiment.
  • the sensor unit 502d includes a lower portion 526d of the sensor housing and the upper portion 512a encapsulating the sensor 216 and the motor 220.
  • the sensor unit 502d may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212.
  • the attachment portion 500d may include any aspect of the attachment portion 500a. 500c.
  • the attachment portion 500d may include a plurality of clips 530d.
  • one or more (e.g., all) of the plurality of clips 530d includes one or more teeth 532d on an inward facing surface of the one or more of the plurality 7 of clips 530d.
  • the one or more teeth 532d may be configured to grip the abutment 104 to facilitate attachment of the attachment portion 500d to the abutment 104.
  • the one or more teeth 532 allows the attachment portion 500d to attach to multiple sizes of abutments 104 (e g., abutments 104 having a variety of diameters).
  • FIG. 6 is a flow diagram of a method 600 of securing a sensor unit to an abutment, according to an embodiment.
  • the method includes providing 605 the sensor unit.
  • the sensor unit may include any of the sensor units disclosed herein.
  • the sensor unit may include a sensor housing having an attachment portion, a motor secured to the sensor housing and configured to exert a lateral force on the implant, and a sensor secured to the sensor housing.
  • the sensor may be configured to measure at least one of vibration or motion of the implant secured responsive to the mechanical force exerted by the motor, and configured to communicate with a control unit.
  • the method includes detachably securing 610 the attachment portion of the sensor housing to an abutment.
  • detachably securing 610 the attachment portion of the sensor housing to an abutment includes press-fitting a shaft extending from a first surface region of the sensor housing into a hole in the abutment, and press-fitting a portion of the abutment within a seating ring protruding from the first surface region and extending at least partially about or around the shaft.
  • detachably securing 610 the attachment portion of the sensor housing to an abutment includes creating three or more contact points between the atachment portion and the abutment effective to selectively secure the attachment portion to the abutment.
  • the one or more members of the atachment portion may include: a ring that is asymmetric and/or oval and defines an opening having a first region with a smaller radius and a second region with a larger radius that is greater than the smaller radius; and a detent element extending through the ring proximate to the second region.
  • Creating three or more contact points between the atachment portion and the abutment effective to selectively secure the atachment portion to the abutment may include: inserting a portion of the abutment into the opening of the ring being sized such that the ring contacts the abutment at two contact points proximate to the first region; and adjusting the detent element to contact the abutment at a third contact point substantially opposite to the first region when the portion of the abutment is received within the opening.
  • the one or more portions of the atachment portion include: a ring that is discontinuous and/or segmented, the ring including a first arced segment and a second segment; and a detent element extending through the second segment.
  • Creating three or more contact points between the atachment portion and the abutment effective to selectively secure the atachment portion to the abutment may include inserting a portion of abutment between the first arced segment and the second segment such that the first arced segment contacts the abutment at two contact points of the first arced segment; and adjusting the detent element to contact the abutment at a third contact point substantially opposite to the first arced segment.
  • the one or more members of the atachment portion include: a ring that is discontinuous and/or segmented, the ring including a first arced segment and a second segment; and a biased plunger extending through the second segment, the biased plunger having a head biased inwardly towards the first arced segment.
  • Creating three or more contact points between the atachment portion and the abutment effective to selectively secure the atachment portion to the abutment may include: inserting a portion of the abutment between the first arced segment and the second segment such that the first arced segment contacts the abutment at two contact points of the first segment; and the biased plunger biasing the head inwards to contact the abutment at a third contact point substantially opposite to the first arced segment.
  • the one or more members of the atachment portion include a plurality of clips extending from a first surface region of the sensor housing and positioned around an axis to form a segmented ring having a first diameter that is less than a diameter of the abutment, the plurality of clips including at least three clips.
  • Creating three or more contact points between the attachment portion and the abutment effective to selectively secure the attachment portion to the abutment may include press-fitting a portion of the abutment within the segmented ring between the plurality of clips.
  • the method 600 may further comprise inserting a positioning pin extending from the first surface region on the axis into a hole in the abutment.
  • the plurality of clips may be compliant and/or angled inwards towards the axis as the plurality of clips extend from the first surface region.
  • the plurality of clips may taper as the plurality of clips extend from the first surface region.
  • At least one clip of the plurality of clips may include one or more teeth on an inward facing surface of that least one clip.
  • detachably securing 610 the attachment portion of the sensor housing to an abutment includes positioning one or more members of the attachment portion on a top surface of the abutment and positioning one or more members of the attachment portion within a hole of the abutment.
  • detachably securing the attachment portion of the sensor housing to an abutment may include: positioning a ring on the top surface of the abutment, the ring being continuous or discontinuous and extending from a first surface region of the sensor housing; and adjusting a detent element extending through the ring inward to contact at least one arm of two arms extending from the first surface region of the sensor housing and directing the two arms closer together, the two arms being spaced apart such that the two arms do not fit within the hole of the abutment until the detent element contacts the at least one arm of the two arms and directs the two arms closer together.
  • detachably securing the attachment portion of the sensor housing to an abutment may include: positioning a ring on the top surface of the abutment, the ring being continuous or discontinuous and extending from a first surface region of the sensor housing; inserting at least a portion of two arms extending from the first surface region of the sensor housing into the hole of the abutment; and extending a wedge or a detent element having a tapered head inward through the ring and towards a center of the ring between the two arms to spread the two arms apart from one another to secure at least the portion of the two arms in the hole of the abutment.
  • detachably securing the attachment portion of the sensor housing to an abutment may include: positioning a ring on the top surface of the abutment, the ring extending from a first surface region of the sensor housing: and adjusting a detent element extending through the ring and a first arm of two arms extending from the first surface region of the sensor housing to spread the two arms further apart to secure a portion of the two arms in the hole of the abutment by contacting a second arm of the two arms.
  • detachably securing the attachment portion of the sensor housing to an abutment may include: positioning a first region of a ring around a portion of the periphery' of the abutment; positioning a second region of the ring on the top surface of the abutment; inserting an arm of the attachment portion at least partially into the hole, the arm being positioned between the first region and the second region of the ring; and adjusting a detent element extending through the second region to contact the arm and direct the arm towards the first region effective to clamp a portion of the abutment between the arm and the first region.
  • Acts of the method 600 are for illustrative purposes.
  • the acts of the method 600 may be performed in different orders, split into multiple acts, modified, supplemented, or combined. Any of the acts of the method 600 may include using any of the sensor units or attachment portions disclosed herein.
  • a method of analyzing stability of an implant is disclosed. The method may include securing a sensor unit to an abutment secured to an implant as described above.
  • the method also may include with a control unit, selecting a tooth position of the implant, selecting a ty pe of the implant, selecting a type of the abutment, directing a motor of the sensor unit to exert a mechanical and/or lateral force on the implant, receiving acceleration of the implant measure by a sensor of the sensor unit; and determining a stability of the implant using a mechanics-base prediction model.
  • the term “about” or “substantially” refers to an allowable variance of the term modified by “about” by ⁇ 10% or ⁇ 5%. Further, the terms “less than,” “or less,” “greater than”, “more than,” or “or more” include as an endpoint, the value that is modified by the terms “less than,” “or less,” “greater than,” “more than,” or “or more.”

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Abstract

Embodiments disclosed herein include a sensor unit for use with a dental stability analyzing system. The sensor unit includes a sensor housing having an attachment portion configured to detachably secure the sensor housing to an abutment. The sensor unit includes a motor secured to the sensor housing and configured to exert a lateral force on the implant. The sensor unit includes a sensor secured to the sensor housing, the sensor being configured to measure at least one of vibration or motion of the implant secured responsive to the mechanical force exerted by the motor, and configured to communicate with a control unit.

Description

SENSOR UNITS FOR USE WITH A MEDICAL IMPLANT STABILITY ANALYZING SYSTEM, AND RELATED SYSTEMS AND METHODS
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application No. 63/492,314 filed on March 27, 2023, and also claims priority to U.S. Provisional Patent Application No. 63/533,856 filed on August 21, 2023, the disclosures of which are incorporated herein, in their entirety, by this reference.
BACKGROUND
[0002] For implant dentistry, the standard of care is to place an implant in bone. Then, an abutment is attached over the implant. After the bone heals, dentists can attach a crown over the abutment to receive bite loads. For an implant to function, a structural and functional connection between the bone and the implant (e.g., osseointegration) should be present. The level of implant immobility as a result of the osseointegration is known as “stability” of the implant.
SUMMARY
[0003] Embodiments disclosed herein include sensor unit for use with a medical implant (including a dental implant) stability analyzing system, and related systems and methods. In an embodiment, a sensor unit includes a sensor housing, a motor, and a sensor secured to the sensor housing. The sensor housing has an attachment portion configured to detachably secure the sensor housing to an abutment. The motor is secured to the sensor housing and configured to exert a lateral force on the implant. The sensor is configured to measure at least one of vibration or motion of the implant secured responsive to a mechanical force exerted by the motor, and further configured to communicate with a control unit.
[0004] In an embodiment, an implant stability analyzing system includes any one of the sensor units disclosed herein, a control unit, and an electronic device. The control unit is configured to communicate with the sensor unit, direct the motor of the sensor unit to exert a mechanical force and/or a lateral force on the implant, and receive acceleration of the implant measured by the sensor of the sensor unit. The electronic device is configured to communicate with the control unit, receive the acceleration measured by the sensor of the sensor unit, and determine a stability of the implant.
[0005] In an embodiment, a method of securing a sensor unit of a medical implant (including a dental implant) stability analyzing system to an abutment is disclosed. The method includes providing the sensor unit, comprising a sensor housing having an attachment portion, a motor secured to the sensor housing and configured to exert a lateral force on the implant; and a sensor secured to the sensor housing, the sensor being configured to measure at least one of vibration or motion of the implant secured responsive to the mechanical force exerted by the motor, and configured to communicate with a control unit. The method includes detachably securing the attachment portion of the sensor housing to an abutment.
[0006] In an embodiment, a method of analyzing stability of an implant is disclosed. The method includes securing a sensor unit to an abutment secured to an implant according to any one of the embodiments disclosed herein. The method includes, with a control unit, selecting a tooth position of the implant, selecting a type of the implant, selecting a type of the abutment, directing a motor of the sensor unit to exert a mechanical and/or lateral force on the implant, receiving acceleration of the implant measure by a sensor of the sensor unit; and determining a stability of the implant using a mechanics-base prediction model.
[0007] Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The drawings illustrate several embodiments of the present disclosure, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.
[0009] FIG. 1A is a partial cross-sectional side view' of a healing abutment on a dental implant, according to an embodiment.
[0010] FIG. IB is an exploded view of a crown, an abutment, and a dental implant. according to an embodiment.
[0011] FIG. 2A is a schematic of a dental implant stability analyzing system, according to an embodiment.
[0012] FIG. 2B is an exploded view of a sensor unit of a dental implant stability analyzing system, according to an embodiment. [0013] FIG. 2C is a bottom isometric view of a sensor unit and an abutment, according to an embodiment.
[0014] FIG. 3A is a top view of an attachment portion of a sensor unit secured to an abutment, according to an embodiment. [0015] FIG. 3B is a top view of an attachment portion of a sensor unit secured to an abutment, according to an embodiment.
[0016] FIG. 3C is a partial cross-sectional side view of the sensor unit of FIG. 3C secured to an abutment, according to an embodiment.
[0017] FIG. 3D is a top view of an attachment portion of a sensor unit secured to an abutment, according to an embodiment.
[0018] FIG. 4A is a partial cross-sectional side view of a sensor unit secured to an abutment, according to an embodiment.
[0019] FIG. 4B is an isometric side view two arms and wedge of an attachment portion of a sensor unit, according to an embodiment. [0020] FIG. 4C is an isometric side view of two arms and a tapered head of a detent element of an attachment portion of a sensor unit, according to an embodiment.
[0021] FIG. 4D is a partial cross-sectional side view of a sensor unit secured to an abutment, according to an embodiment.
[0022] FIG. 4E is a partial cross-sectional side view of a sensor unit secured to an abutment, according to an embodiment.
[0023] FIG. 5A is a partial cross-sectional side view of a sensor unit secured to an abutment, according to an embodiment.
[0024] FIG. 5B is an isometric bottom view of an attachment portion of the sensor unit of FIG. 5A, according to an embodiment. [0025] FIG. 5C is a side view of a sensor unit secured to an abutment, according to an embodiment.
[0026] FIG. 5D is a side view of a sensor unit secured to an abutment, according to an embodiment.
[0027] FIG. 6 is a flow diagram of a method of securing a sensor unit to an abutment. according to an embodiment.
DETAILED DESCRIPTION
[0028] Embodiments disclosed herein include dental implant stability analyzing devices, sensor units having an attachment element, and related systems and methods of use. The dental implant stability analyzing devices may include electro-mechanical devices that measures stability of a dental implant in bone. In many embodiments, a dental implant stability’ analyzer is a device or system to measure the level of osseointegration of an implant. In an embodiment, a sensor unit for use with a medical implant (including a dental implant) stability’ analyzing system includes a base having a seating member protruding from the base and configured to secure the sensor unit to an abutment. The senor unit includes a motor secured to the base and configured to exert a lateral force on the implant. The sensor unit further includes a sensor secured to and electrically coupled to the motor, the sensor being configured to measure at least one of vibration or motion of the implant secured responsive to the mechanical force exerted by the motor, and configured to communicate with a control unit.
[0029] Conventional stability analyzers typically require removal of the crown and the abutment. A sensor unit of the analyzers is then typically threaded onto the implant to take measurements. After the stability’ is measured, the sensor unit is removed and the abutments and crow ns are restored. This process of removal (and restoration) is a cumbersome process that consumes the time of the dentist. Furthermore, the removal of the conventional sensor unit involves a risk of accidentally disturbing the implant or accidentally dropping parts down the throat of the patient, thus raising a safety issue. Moreover, implants under different brands have different threads and dimensions. Therefore, conventional sensor units cannot be interchanged among different brands of implants. This variance in implants translates into a wide spectrum of sensor units to accommodate different implant brands, resulting in huge design, manufacturing, and inventory costs.
[0030] Embodiments of sensor units disclosed herein include a universal coupler, through which a sensor unit can be attached onto a crown or an abutment. While healing abutments are specifically referenced in certain embodiments described herein, the sensor units may be configured to attach any of a number of different dental abutments, such as healing abutments, locator abutments, multi-unit abutments, impression copings, etc. Furthermore, embodiments of the sensor units described herein may be configured to attach to dental healing caps. Since there is no need to remove the abutment or crown, embodiments of the sensor unit are easier, faster, and safer to use with the universal coupler. Moreover, the coupler can attach onto abutments and crowns of arbitrary geometry, allowing the sensor unit to be one-size-fits-all, significantly saving the costs.
[0031] In some embodiments, the universal coupler of a sensor unit includes two or more sections of semi-circular inner surfaces. The two or more sections of semi-circular inner surfaces may be hinged or secured together at one point to allow relative rotation. At the opposite side of the hinge, the two sections may be engaged via a locking mechanism. Therefore, the two or more sections of semi-circular inner surfaces may be configured to lock onto an abutment or a crown. The ability to rotate and lock allows the coupler to adjust itself to accommodate different diameters of the abutment. The two or more semi-circular inner surfaces may include at least an end stop, a side wall, and a taper. When the two or more sections are locked onto an abutment, the surface features form a three-point contact with the abutment, thus accommodating abutments of arbitrary shapes.
[0032] Dental implant stability refers to immobility of a dental implant in its surrounding bone. High implant stability is an indicator of successful osseointegration, which manifests in strong functional and structural connection between the implant and the bone. Implant stability is a vital sign reflecting the well-being of an implant throughout its life cycle.
[0033] FIG. 1A is a partial cross-sectional side view of implant healing assembly 100a including a healing abutment 104 on a dental implant 102, according to an embodiment. In implant dentistry, the standard of care is to place an implant in bone 108 in the gum tissue 106 of a patient. The healing abutment 104 is then attached over the implant 102 to shape the gum tissue 106. FIG. IB is an exploded view of an implant crown assembly 100b including a crown 110, an abutment 112, and the dental implant 102, according to an embodiment. After the bone 108 heals, dentists typically replace the healing abutment 104 with the abutment 112, on which the crown 110 will be attached to receive bite loads.
Before placing the crown 1 10, dentists must assure that the implant 102 has enough stability (i.e., pre-crown stability). Otherwise, complications — such as pain, bone loss, or even failure — may occur after the crown 110 is secured to the implant 102. If, for example, a dentist finds low stability of the implant 102 in the bone 108, the dentist may choose to let the bone 108 heal longer or take remedial actions. Even after the crown 110 is successfully placed, a dentist may desire to regularly check the stability of the implant 102 (i.e., postcrown stability). Many dentists, however, rely on subjective measures to evaluate implant stability, such as visual inspection, touch of hands, X-ray images, or torqueing the implant. These subjective measures by the dentist may inaccurately indicate the implant 102 is stable when it is unstable, or inaccurately indicated the implant is unstable when it is stable.
[0034] Systems and methods described may include an electro-mechanical device that measures pre-crown and post-crown stability of the implant 102 in the bone 108. Systems and method described herein may utilize a model-based measurement tool supported by rigorous mechanical principles. Systems and methods described herein may measure a physical quantity' called “angular stiffness” (unit: N.m) to indicate implant stability'. Conceptually, angular stiffness is the ability of the bone to hold the implant against bending at the junction of the abutment and the implant. Higher bone-implant bonding strength implies higher ability- to withstand bending, thus resulting in higher angular stiffness. Since angular stiffness is a physical quantity, angular stiffness can be measured using a standardized specimen and a standardized operating procedure. Therefore, angular stiffness measurements can be repeated and verified by anyone and anywhere. Accordingly, angular stiffness measurements can be calibrated, traced, and verified scientifically, independently, and objectively. Angular stiffness is not an artificial nor an empirical index. The devices, assemblies, and methods described herein may be utilized with methods and systems to measure and evaluate stability of medical implants (including dental implants) described and disclosed in U.S. Patent Application No. 16/489,028, the disclosure of which is incorporated herein, in its entirety, by this reference. The devices and assemblies described herein may be utilized with methods and devices to measure angular stiffness of dental and medical implants (including dental implants) described and disclosed in PCT Application No. PCT/US2022/017795. the disclosure of which is incorporated herein, in its entirety, by this reference.
[0035] FIG. 2A is a schematic of a dental implant stability analyzing system 200, according to an embodiment. In some embodiments, the dental implant stability analyzing system 200 may include a sensor unit 202 (e.g. , a disposable sensor unit), a reusable control unit 204, and an application 210 (e.g, module) on an electronic device (e.g., a smartphone or a tablet computer). The sensor unit 202 may be secured to the healing abutment 104 with a quick-connect-fast-release mechanism (e.g., via the embodiments of FIGS. 2B-6D). The sensor unit 202 may be wired or wirelessly (e.g, Wi-Fi or Bluetooth) connected 206 to the control unit 204, and the control unit 204 may be wired or wirelessly connected 208 to the application 210 on the electronic device. In some embodiments, the control unit 204 and the application 210 may be included on a single electronic device. Generally, when the sensor unit 202 is secured to the healing abutment 104. the implant 102 receives a lateral force (e.g. is wiggled and/or vibrated) by a motor 220 (shown in FIG. 2B) of the sensor unit 202, and the motion thereof is sensed to determined stability through the healing abutment 104. When the dental implant stability7 analyzing system 200 is in use, the sensor unit 202 is first attached onto the healing abutment 104 (for pre-crown stability), according to an embodiment. As provided above, the sensor unit 202 also may alternatively be attached to a locator abutment, a multi-unit abutment, an impression coping, or a healing cap. The sensor unit 202 may then be driven by the motor 220. responsive to instructions from the control unit 204 and/or the application 210 on the electronic device, effective to exert a lateral force on (e.g, wiggle or vibrate) the implant 102 (through the healing abutment). The sensor 216 (e.g., an accelerometer) in the sensor unit 202 may then sense any movement or motion of the implant 102. Finally, the measured motion (e.g., in acceleration) of the implant 102 may be converted to stability (e.g., in angular stiffness) through an accurate, mechanics-based model that resides in the application 210 on the electronic device. Moreover, the mechanics-based model is experimentally validated in benchtop tests before being uploaded into the mobile app, according to an embodiment. [0036] The schematic of the dental implant stability analyzing system 200 of FIG. 2A and the operation described above also may apply to post-crown stability measurements, with the exception of the healing abutment 102 shown in FIG. 2A is replaced by the abutment 112 and crown 110 shown in FIG. IB. In such an implementation of the dental implant stability7 analyzing system 200, the sensor unit 202 may be attached to the crown 110, rather than the healing abutment 104, for post-crown stability measurements. While pre-crown stability measurements are provided herein to describe the design and functionality of the dental implant stability analyzing system 200, the measurements also may be applied to post-crown stability7 measurements.
[0037] FIG. 2B is an exploded view of the sensor unit 202 of the dental implant stability7 analyzing system 200, according to an embodiment. The sensor unit 202 may include a sensor housing 226, a sensor cover 212, motor 220 (e.g. , a brushless DC (BLDC) motor), a sensor 216 (e.g, an accelerometer, a micro-electro-mechanical system (MEMS) accelerometer, or a g-sensor), a printed circuit board (PCB) 218, and a connector 214 configured to operably connect to the control unit 204. The sensor unit 202 also may include lead wires between the PCB 218 and the connector 214 and between the motor 220 and the PCB 218. In an embodiment, as alternative or in addition to the motor 220 being an electric motor, the motor 220 may be configured as an electromagnetic motor, a linear resonance actuator, a piezoelectric element, a magnetic element, or another suitable force generating element or actuator. Depending on the materials used, the sensor 216 may result in a single-use, disposable sensor unit 202 or a reusable sensor unit 202 suitable for sterilization via autoclaves. In an embodiment, the sensor housing 226 and the sensor cover 212 may be suitable for sterilization (e.g., via an autoclave), while the sensor 216 and the motor 220 are removable from the sensor housing 226 for reuse in a sterile sensor housing [0038] The sensor housing 226 and the sensor cover 212 are made of plastics through injection molding, according to an embodiment. The sensor housing 226 and the sensor cover 212 may include mating steps and flanges (or grooves), such that the sensor cover 212 is configured to close snugly onto the sensor housing 226. The sensor housing 226 may include a first cavity7 224 (e.g. , a substantially circular cavity) and a second cavity7 222 (e.g. , a substantially square cavity) to accommodate the motor 220 and the sensor 216/PCB 218, respectively. The sensor housing also may include notches 223. 225 to accommodate lead wires connecting the motor 220, the sensor 216, and the connector 214 to the control unit 204, according to an embodiment. [0039] In some embodiments, the motor 220 may include an off-the-shelf haptic motor configured to produce a small and gentle force to wiggle the implant, such as a haptic coin motor. The voltage to operate the motor 220 may be less than 3 volts direct current (DC), and the force produced by the motor 220 may generally be less than about 1 Newton. Displacement of the implant 102 by the motor may be less than 20 pm for low-density bone (15 pound-per-cubic-foot density7).
[0040] The sensor 216 may be surface mounted onto a rigid or a flexible PCB 218, according to an embodiment. In some embodiments, the sensor 216 may include a digital triaxial acceleration sensor mounted on the flexible PCB 218. Through the traces inside the flexible PCB 218, the sensor 216 may be electrically connected to a pin connector, which may be subsequently connected to the control unit 204. The sensor 216 and the PCB 218 have a small footprint (e.g, about 3 mm by about 3 mm), according to an embodiment. Moreover, the trace between the sensor 216 and the PCB 218 and the pin connector 214 may be sufficiently long (e.g, at least about 20 cm), so that the pin connector 214 will be situated far outside of the oral cavity of the patient, according to an embodiment. The pin connector 214 may then be electrically connected 206 to the control unit 204 via a long, shielded flex cable. Therefore, the control unit 204 may be remote enough from patents when the dental implant stability analyzing system 200 is in use.
[0041] The sensor housing 226. the sensor cover 212, the motor 220, and the sensor 216 may be assembled as illustrated in the exploded view of FIG. 2B, according to an embodiment. First, the motor 200 may be soldered or otherwise coupled to the sensor 216 and the PCB 218 via lead wires. This securement allows the motor 220 to receive power through the lead wires from the control unit 204. [0042] The motor 220 may then be assembled or disposed into the first cavity 224 of the sensor housing 226. In particular, the first cavity 224 may be designed to be slightly smaller than the diameter of the motor 220. The motor 220, then, may be press-fit into the first cavity 224 of the sensor housing 226. In some embodiments, a drop of epoxy or other adhesive is laid between the motor 220 and the base of the first cavity 224 to further secure the motor 220 to the sensor housing 226, according to an embodiment.
[0043] The sensor 216 and the PCB 218 may then be assembled into the second cavity 222 of the sensor housing 226. In particular, the second cavity 222 may be slightly larger than the sensor 216 and the PCB 218 according to an embodiment, so that the sensor 216 and the PCB 218 may be positioned within the second cavity 222 without obstruction. A drop of epoxy or other adhesive may be laid between the PCB 218 and the base of the second cavity 222 to further secure the sensor 216 in place. Moreover, the sensor housing 226 also may be designed to have the two notches 223, 225 accommodating the lead wires and traces. [0044] The sensor cover 212 may then be closed on the sensor housing 226. The seam present between the sensor cover 212 and the sensor housing 226 may be sealed with silicone rubber or other suitable sealant. The notch 223 accommodating traces to the control unit 204 may also be sealed with silicone rubber. With the assembly process, the sensor unit 220 will have adequate package to assure electric insulation as well as waterproofness. [0045] While many embodiments of sensor units disclosed herein are configured as a single-use, disposable unit, in some embodiments, the sensor unit may be configured for use as a reusable sensor unit. For example, the sensor housing 226 and the sensor cover 212 may be made of titanium alloy, which is the same material as typically used in many implants and healing abutments. In some embodiments, the sensor housing 226 and/or the sensor cover 212 may include one or more of titanium, titanium alloy, aluminum, aluminum alloy, steel, and/or stainless steel. Moreover, the sensor cover 212 and the sensor housing 226 may include slight interference (or mating grooves) so that the sensor cover 212 can close snugly on the sensor housing 226 without falling apart on its own. The motor 220 and the sensor 216 can be encapsulated in resin, for example, as a single and solid unit for electric insulation and waterproofhess. Also, the encapsulated motor 220, PCB 218, and sensor 216 unit may be removable from the sensor housing 226 as one single module.
[0046] When the sensor unit 202 is used as a reusable component, the encapsulated motor 220, PCB 218, and sensor 216 unit may first be placed into the sensor housing 226. The sensor cover 212 may then close snugly onto the sensor housing 226. Any opening of the sensor housing 226 to the oral cavity may be sealed with, for example, petroleumjelly. After stability measurements are completed, the sensor unit 202 may be removed from the healing abutment 104. The sensor cover 212 may then be opened, and the encapsulated motor 220, PCB 218, and sensor 216 unit may be removed and chemically disinfected. The titanium sensor cover 212 and sensor housing 226 may be sterilized in autoclaves ready for their next use.
[0047] The sensor housing 226 has an attachment portion configured to facilitate a fast connection to and an easy release from the healing abutment 104, according to an embodiment. FIG. 2C is a bottom isometric view of the sensor unit 202 and an abutment 104, according to an embodiment. An attachment portion may be disposed on the bottom surface 227 or base of the sensor housing 226. In some embodiments, the attachment portion of the sensor unit 202 includes a central shaft 228, a concentric seating ring 230, and a radial release slot 232. These features of the sensor unit 202 may form a universal coupler, according to one embodiment. While the attachment portion of the sensor unit 202 (as well as other attachment portions disclosed herein) include reference to attachment of the sensor unit 202 to a healing abutment 104, the sensor unit 202 also may alternatively be attached to a locator abutment, a multi-unit abutment, an impression coping, or a healing cap.
[0048] In some embodiments, the seating ring 230 may extend less than about 1 mm from a bottom surface 227 of the sensor housing 226. For example, the seating ring 230 may extend less than about 0.75 mm, less than about 0.5 mm, less than about 0.4 mm, less than about 0.3 mm, less than about 0.25 mm, about 0.2 mm to about 0.8mm, about 0.2 to about 0.7 mm, about 0.2 mm to about 0.6 mm, about 0.2 mm to about 0.5 mm, about 0.2 mm to about 0.4 mm, or about 0.2 mm to about 0.3 mm from the bottom surface 227 of the sensor housing 226. In some embodiments, the seating ring 230 may include a radial thickness of about 0. 1 mm to about 0.5 mm, about 0. 1 mm to about 0.3 mm, about 0.1 mm to about 0.2 mm, about 0. 15 mm to about 0.25 mm, or about 0.2 mm to about 0.3 mm.
[0049] The central shaft 228 may be slightly bigger than the hole 234 of the healing abutment 104, thereby resulting in a slight interference fit or press-fit when inserting the central shaft 228 into the hole 234 of the healing abutment 104. The central shaft 228 may be threadless (e.g. , threads may be absent from the central shaft 228 or the central shaft 228 is not threaded). The central shaft 228 may include a cross-sectional shape generally complementary to the hole in the healing abutment, such as circular, hexagonal, hexalobular, etc. In an embodiment, the central shaft 228 may be tapered with a conical contact/outer surface.
[0050] When the central shaft 228 is inserted into the hole 234, the healing abutment 104 may be press-fit onto the central shaft 228 on the bottom surface 227 of the sensor housing 226 forming a firm connection. In some embodiments, the seating ring 230 includes a diameter that is about 70% to about 90%. about 75% to about 85%, about 70%, about 75%. about 80%, about 85%, or about 90% of a diameter of the abutment 104. The seating ring 230 may be configured to significantly increase the contact area of the sensor housing 226 with the healing abutment 104, thus making the sensor unit 202 more stable as the motor 220 exerts a lateral force on the implant 102. Because the top surface of many healing abutments 104 is curved, the seating ring 230 is configured to allow the sensor housing 226 to attach onto healing abutments 104 of many shapes. If needed, temporary dental cement or adhesive may be applied around and outside the seating ring 230 to assist attachment of the sensor housing 226 onto the healing abutment 104. For certain teeth (e.g., incisors) locations, the central shaft 228 and the seating ring 230 can be made longer so that the sensor housing 226 is above neighboring teeth to avoid interference.
[0051] The radial release slot 232 may be positioned for a dental professional to release the sensor housing 226 from the healing abutment 104. For example, a dental professional may insert the tip of a dental hand tool in the release slot 232, and pry the sensor housing 226 (and thus the sensor unit 202) out of the healing abutment 104.
[0052] The dental implant stability analyzing system 200 may include the control unit 204 (main body) and a shielded flex cable 206 (accessory) connecting the control unit 204 to the sensor 216 via the connector 214. In some embodiments, the control unit 204 may be battery-powered and include an on-off switch that activates and deactivates the control unit 204. The control unit 204 may include a digital display that shows the voltage driving the motor 220 and error messages (when an error occurs). The control unit 204 may include a control knob that activates and deactivates the display and adjusts the voltage to the motor 220, according to an embodiment. The control unit 204 may include a microprocessor. Upon receiving instructions from the application 210 on the electronic device, the microprocessor instructs the sensor unit 202 to exert a lateral force on the implant 102, receives the measured acceleration from the sensor unit 202, and transmits the measured data to the application 210.
[0053] In many embodiments, the function of the application 210 on the electronic device is (a) to command the control unit 204 and the sensor unit 202 to conduct measurements and (b) to extract stability from the measured data. In some embodiments, application 210 on the electronic device uses Bluetooth® to communicate with the control unit 204. In some embodiments, the application 210 is integrated or embedded in the control unit 204 (e.g, a single electronic device may include both the control unit 204 and the application 210). Generally, the application 210 on the electronic device may be configured to allow a dental professional or other use to select a tooth position, select an implant type, select a type of abutment or cap, instruct the motor 220 to exert a lateral force on the implant 102, utilize a mechanics-based prediction model, and output measure stability of the implant. [0054] In some embodiments, the application 210 includes a user interface (UI) module. The UI may be configured to allow users to remote-control the dental implant stability analyzing system 200 hardware to perform stability measurements. The UI also may be configured to receive the measurement data and displays the final results, such as implant stability. [0055] The front end of the UI module may be configured to receive input. Users may select a tooth location (e.g.. tooth number 1-32) from a tooth chart, reflecting the exact location of the implant whose stability is to be measured. Users may then select the implant used — such as brand, type, diameter, and length — through dropdown menus. Finally, users may select the healing abutment used — again the brand, type, diameter, and length. These input parameters will be stored for a data processing unit of at least one of the application 210 or the control unit 204.
[0056] Next, the UI may be configured to allow users to activate the stability measurements. Upon receiving the command from the UI, an execution module of at least one of the application 210 or the control unit 204 may activate the control unit and the sensor unit via Bluetooth. After the measurements are completed, the execution module may transfer the measured data from the control unit back to the mobile app via Bluetooth. Both the input parameters and the measured data may be forw arded to the data processing module to extract the stability.
[0057] After the implant stability is extracted, the back end of the UI may be configured to present the extracted stability to users in the form of angular stiffness (unit: N.m). The presentation may be numerical and/or graphical, according to an embodiment. The UI may also inform users how the extracted angular stiffness should be interpreted. For example, dentists generally obtain a feel of implant stability through insertion torques, implant stability quotient (IS Q), and drilling artificial bone of various densities. The UI may present the extracted angular stiffness in conjunction with equivalent insertion torque, ISQ, and artificial bone density. Based on the measured angular stiffness and its interpretation, dentists can make a better diagnosis of implant stability.
[0058] At least one of the control unit 204 or the application 210 may include a data processing module. The data processing module may include a mechanics -based prediction model, according to an embodiment. After the processing module receives the input parameters from the front-end UI as well as the measured data from the execution module, the data processing module may then use the mechanics-based prediction model to extract the angular stiffness to indicate stability based on the input parameters and the measured data.
[0059] The system 200 may adopt angular stiffness to indicate dental implant stability, an accurate mechanics-based model to allow prediction and extraction of angular stiffness, and benchtop calibration and validation to ensure accuracy of the mechanics-based model. More details regarding the adoption of angular stiffness to indicate dental implant stability', an accurate mechanics-based model to allow prediction and extraction of angular stiffness, and benchtop calibration and validation to ensure accuracy of the mechanics-based model are described and disclosed in U.S. Patent Application No. 16/489,028 and PCT Application No. PCT/US2022/017795, the disclosures of each which are incorporated herein, in their entirety, by this reference. Dental implant stability analyzing systems described herein may then be used to measure the angular stiffness and compared with the calibration. The accuracy of dental implant stability analyzing systems is above 90% for low-density' bones. In addition, the insertion torque and ISQ are also measured in the standardized tests. Therefore, the measured angular stiffness can be benchmarked against the insertion torque, ISQ, and Sawbones® density. [0060] Embodiments of the sensor units disclosed herein may include various configurations and structures of an attachment portion of the sensor housing that allow the sensor housing to be selectively attached to a cap or abutment. FIGS. 3A-5D are various views of attachment portions of various embodiments of sensor housings and sensor units configured to attach to the cap or abutment. Unless otherwise noted, sensor housings including the attachment portions shown in FIGS. 3A-5D may include any aspect of the sensor housing shown and described above in relation to FIGS. 2A-2C. For example, the attachment portions shown in FIGS. 3A-5D replace the seating ring 230 and/or the central shaft 228 of the sensor unit 202. According to various embodiments, the attachment portion of the sensor housing may be configured for a central attachment to the cap or abutment, an outer (or perimeter) attachment to the cap or abutment, or a hybrid combination of central and outer attachments to the cap or abutment.
[0061] FIG. 3A is a top view of an attachment portion 300a of a sensor unit secured to an abutment 104 (e.g., cap), according to an embodiment. In FIG. 3A, the upper portion of the sensor housing 226 is removed to allow viewing of the attachment portion 300a of the sensor housing 226, according to an embodiment. The attachment portion 300a of FIG. 3A utilizes or is configured to secure to an outer periphery of the abutment 104. The attachment portion 300a, then, may not secure to the hole 234 of the abutment 104, according to an embodiment. In some embodiments, the attachment portion 300a of the sensor housing 226 includes a ring 330a that is oval and/or asymmetric and a determent element, such as a set screw 332a, pin, biasing element (e.g., a compression spring), or other detent secured or securable to the ring 330a. The ring 330a shown in FIG. 3A may replace the seating ring 230 of the sensor unit 202, and the shaft 228 and/or the release slot 232 of the sensor housing 226 may be absent from the sensor housing used with the attachment portion 300a shown in FIG. 3A. In some embodiments, the ring 330a is positioned on a base secured to the sensor housing and/or includes a greater diameter or width than the sensor housing (rather than the smaller diameter of seating ring 230 relative to the sensor housing 226 of the sensor unit 202 in FIG. 2C.
[0062] The ring 330a may extend from the bottom surface 227 away from the cover 212 to any distance described above in relation to the seating ring 230. In some embodiments of the attachment portion 300a, the ring 330a that is oval and/or asymmetric may extend from the bottom surface 227 and defines an opening 331a sized to receive a top portion of the abutment 104 therein. The opening 331a may include a first region 331a’ with a smaller radius and a second region 331a” with a larger radius relative to the smaller radius of the first region. In some embodiments, larger radius of the second region 331a” may include a radius that is about 1.5 times, about 2 times, about 2.5 times, or about 1.5 times to about 2.5 times greater than the smaller radius of the first region 331a'. For example, in an embodiment used with an abutment 104 having a 4.5 mm diameter, the smaller radius of the first region 331a’ may be about 1.5 mm and the larger radius of the second region 331 ” may be about 3 mm. Accordingly, in some embodiments, the smaller radius of the first region 331a’ is less than a radius of the abutment 104 and the larger radius of the second region 331a” is greater than a radius of the abutment 104. The second region 331a” may be generally opposite to the first region 331a’ of the opening 331a. This configuration of the opening 331a in the ring 330 allows the top portion of the abutment 104 to be inserted into the opening. The sensor housing 226 may then be moved or adjusted to position the abutment 104 at least proximate to the first region 331a’ of the opening 331a having the smaller radius. This oval and/or asymmetric configuration of the opening 331a in the ring 330 creates at least two contact points 336 between the ring 330 and the abutment 104 at the first region 331a’ of the opening 331a.
[0063] The set screw 332a may be threadedly secured or securable to the ring 330 proximate to the second region 33 la” of the opening 331a including the larger radius. The set screw 332a is selectively adjustable and, when the top portion of the abutment 104 is positioned within the opening 331a of the ring 330a, the set screw 332a may be rotated to extend the set screw 332a further into the opening 331a. As the set screw 332a is extended further into the opening 331a, the set screw 332a may contact the abutment 104 and create a third contact point 336 on the abutment 104 (in addition to the two contact points 336 between the abutment 104 and the ring 330). The set screw 332a may then be adjusted to tighten the abutment 104 between the three contact points 336, thereby securing the abutment to the attachment portion 300a and the sensor housing 226.
[0064] This configuration of the attachment portion 300a allows a single sensor housing 226 to be attached to various sizes of abutments 104 and still provide the described three-point contact 336. In some implementations of the attachment portion 300a, gum tissue 106 may be around at least a portion of the abutment 104 or may extend closer to the top of the abutment 104 than other regions around the abutment 104. The attachment portion 300a may be positioned such that the set screw 332a is aligned with the side of the abutment 104 having gum tissue 106 extending closer to the top of the abutment 104. As the set screw 332a has less surface area and is more easily aimed, the set screw 332a may more easily contact the abutment 104 without contacting the gum tissue 106 than the ring 330 at the first region 331a’ of the opening 33 la having the smaller radius.
[0065] FIG. 3B is a top view of an attachment portion 300b of a sensor unit 302b secured to an abutment 104 with the sensor housing removed for viewing of the attachment portion 300b, and FIG. 3C is a partial cross-sectional side view of the sensor unit 302b of FIG. 3C secured to an abutment, according to an embodiment. In some embodiments, the sensor unit 302b includes a lower portion 326c of the sensor housing and an upper portion 312c encapsulating the sensor 216 and the motor 220. The upper portion 312c may include a smaller diameter or width than the lower portion 326c of the sensor housing of the sensor unit 302b. In some embodiments, with the exception of the attachment portion 300b, the sensor unit 302b may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212.
[0066] The attachment portion 300b may utilize or be configured to attach to an outer periphery of the abutment 104. In some embodiments, the attachment portion 300b of the sensor unit 302b includes a partial or segmented ring 330b, 330c that is at least partially oval and/or asymmetric and a detent element such as a set screw 332b, pin, or other detent secured or securable to the segmented ring 330b, 330c. The segmented ring 330b. 330c may replace the ring 230 of the sensor unit 202, and the shaft 228 and/or the release slot 232 of the sensor unit 202 may be absent from the sensor housing of the sensor unit 302b used with the attachment portion 300b. In some embodiments, the segmented ring 330b, 330c is positioned on the lower portion 326c of the sensor housing and/or includes a greater diameter or overall dimension than the upper portion 312c. The segmented ring 330b, 330c may extend from the bottom surface of the lower portion 326c of the sensor housing away from the upper portion 312c to any distance described above in relation to the seating ring 230.
[0067] In some embodiments, the segmented ring 330b. 330c that is oval and/or asymmetric may include at least a first segment 330c and a second segment 330b defining a gap 33 lb or space between the first segment 330c and the second segment 330b. The first segment 330c may be arced at a smaller radius and the second segment 330b may be arced with a larger radius relative to the smaller radius of the first segment 330c. The second segment 330b may be generally opposite to the first segment 330c. This configuration of the gap 331b between the segments of the segmented ring 330b, 330c allows the top portion of the abutment 104 to be inserted into the gap 331b between the first segment 330c and the second segment 330b. The bottom portion 326c of the sensor housing may then be moved or adjusted to position the abutment 104 at least proximate to the first segment 330c having the arc with the smaller radius. This oval and/or asymmetric configuration of the segmented ring 330b, 330c creates at least two contact points 336 between the first segment 330c and the abutment 104.
[0068] The set screw 332b may be threadedly secured or securable to the second segment 330b that includes the arc having the larger radius. The set screw 332b is selectively adjustable and, when the top portion of the abutment 104 is positioned between the first segment 330c and the second segment 330b, the set screw 332b may be rotated to extend the set screw 332b further into the gap 331b between the first segment 330c and the second segment 330b. As the set screw 332b is extended further into the gap 331b between the segments of the segmented ring 330b, 330c, the set screw 332b may contact the abutment 104 and create a third contact point 336 on the abutment 104 (in addition to the two contact points 336 between the abutment 104 and the first segment 330c). The set screw 332b may then be adjusted to tighten the abutment 104 between the three contact points 336, thereby securing the abutment 104 to the attachment portion 300b and the sensor unit
302b.
[0069] This configuration of the attachment portion 300b allows a single sensor unit 302b to be attached to various sizes of abutments 104 and still provide the described three- point 336 contact. In some implementations of the attachment portion 300b, gum tissue 106 may be around at least a portion of the abutment 104 or may extend closer to the top of the abutment 104 than other regions around the abutment 104. The attachment portion 300b may be positioned such that the set screw 332b is aligned with the side of the abutment 104 having gum tissue 106 extending closer to the top of the abutment 104. As the set screw 332b has less surface area and is more easily aimed, the set screw 332b may more easily contact the abutment 104 without contacting the gum tissue 106 than the first segment 330c having the smaller radius.
[0070] FIG. 3D is a top view of an attachment portion 300d of a sensor unit secured to an abutment 104 with the sensor housing removed to allow viewing of the attachment portion 300d and the abutment 104, according to an embodiment. Unless otherwise noted, the attachment portion 300d may include any aspect of the attachment portion 300b. In some embodiments, the attachment portion 300d includes the partial or segmented ring 330b, 330c that is oval and/or asymmetric and an inwardly biased plunger 332d secured or securable to the second segmented ring 330b rather than the set screw 332b of the attachment portion 300d. [0071] The inwardly biased plunger 332d may be secured or securable to the second segment 330b that includes the arc having the larger radius. The biased plunger 332d may include a shaft secured to the second segment 330b and a head having a larger diameter or width than the shaft. A biasing element 333d. such as a coiled compression spring or resilient material (e.g., rubber), may be disposed between the head of the plunger 332d and the concave inner surface of the second segment 330b. Other embodiments may include various biasing elements. In some embodiments, the shaft extends through the second segment 330b such that the shaft may slide through the second segment 330b as a force is applied to the head of the plunger 332d to counteract the biasing element 333d. In some embodiments, the plunger 332d includes a grip or attachment region (not shown) generally opposite to the head. The grip or attachment region may include a diameter or width larger than the shaft and/or a hole in the second segment 330b through which the shaft extends.
[0072] As the plunger 332d is biased further into the gap 331b between the segments 330b, 330c, the head may contact the abutment 104 and create a third contact point 336 on the abutment 104 (in addition to the two contact points 336 between the abutment 104 and the first segment 330c). The biasing element 333d may tighten the abutment 104 between the three contact points 336. thereby securing the abutment 104 to the attachment portion 300d and the sensor housing.
[0073] This configuration of the attachment portion 300d allows a single sensor unit to be attached to various sizes of abutments 104 and still provide the described three-point
336 contact. In some implementations of the attachment portion 300d, gum tissue 106 may be around at least a portion of the abutment 104 or may extend closer to the top of the abutment 104 than other regions around the abutment 104. The attachment portion 300d may be positioned such that the plunger 332d is aligned with the side of the abutment 104 having gum tissue 106 extending closer to the top of the abutment 104. As the plunger 332d has less surface area and is more easily aimed, the plunger 332d may more easily contact the abutment 104 without contacting the gum tissue 106 than the first segment 330c having the smaller radius.
[0074] FIG. 4A is a partial cross-sectional side view of a sensor unit 402a having an attachment portion 400a secured to an abutment 104, according to an embodiment. In some embodiments, the sensor unit 402a includes a lower portion 426a of the sensor housing and an upper portion 412a encapsulating the sensor 216 and the motor 220. The upper portion 412a may include a smaller diameter or width than the lower portion 426a of the sensor housing of the sensor unit 402a. In some embodiments, with the exception of the attachment portion 400a, the sensor unit 402a may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212.
[0075] The attachment portion 400a may utilize the hole 234 in the abutment 104 to attach the sensor unit 402a to the abutment 104. In some embodiments, the attachment portion 402a of the sensor housing includes a complete or segmented outer ring 430a, two flexible arms 442a, 444a, and a determent element such as a set screw 432a extending through the outer ring 430a to contact at least one arm of the two arms 442a, 444a. The ring 430a, the two flexible arms 442a, 444a, and the set screw 432a may replace the ring 230 of the sensor unit 202, and the shaft 228 and/or the release slot 232 of the sensor unit 202 may be absent from the lower portion 426a of the sensor housing used with the attachment portion 400a.
[0076] The ring 430a may extend from the bottom surface 427 of the lower portion 426a of the sensor housing to any distance described above in relation to the seating ring 230. In contrast to the attachment portions 300a, 300b, 300d, the outer ring 430a (whether complete or segmented) may be sized to rest on top of the abutment 104 rather than receive the top portion of the abutment 104 within the ring 430a. The two flexible arms 442a. 444a extend further from the bottom surface 427 than the ring 430a such that the two flexible arms 442a, 444a may extend at least partially into the hole 234 while the ring 430a sits atop the abutment 104. The two flexible arms 442a, 444a may be positioned or spaced such that the two arms 442a. 444a do not fit within the hole 234 (e.g., opening) of the abutment 104 unless compressed and/or pressed closer together. In some embodiments, at least one of the arms 442a, 444a is biased outward towards the outer ring 430a.
[0077] The set screw 432a may be threadedly secured or securable to the outer ring 430a. The set screw 432a is selectively adjustable and, when the outer ring 430a is positioned on the top portion of the abutment 104, may be rotated to extend the set screw 432a further into the opening 431a of the outer ring 430a to contact a first arm 444a of the two arms 442a, 444a. As the set screw 432a is extended further into the opening 431 of the ring 430 while contacting the first arm 444a of the two arms 442a, 444a. the set screw 432a may compress the two arms 442a. 444a or push the two arms 442a, 444a closer together until at least a terminating end region of the two arms 442a, 444a fits within the hole 234 in the abutment 104. In some embodiments, the set screw7 432a may press an outwardly biased arm of the two arms 442a, 444a inward until at least some of each of the two arms 442a. 444a fit within the hole 234 in the abutment 104. [0078] Once the terminating end regions of the two arms 442a, 444a are at least partially disposed in the hole 234 of the abutment 104, the set screw 432a may be partially withdrawn from the opening 431a of the outer ring 430a by rotating the set screw7 432a in an opposite direction to the rotation that extends the set screw 432a further into the opening 431 a of the outer ring 430a. Partially withdrawing the set screw 432a may at least partially release the force exerted by the set screw7432a on at least the first arm 444a of the two arms 442a, 444a, thereby allowing the terminating end regions of the tw o arms 442a, 444a disposed in the hole 234 to spread further apart or expand in the hole 234. This spreading apart or expansion of the two arms 442a, 444a in the hole 234 causes the two arms 442a, 444a to contact portions of the abutment 104 defining the hole 234, thereby securing the two arms 442a, 444a partially in the hole 234, and securing the sensor housing to the abutment 104. In some embodiments, the hole 234 in the abutment may include a starshaped hole, and each of the two arms 442a, 444a may be secured within a different point of the star to more effectively secure the two arms 442a, 444a to the abutment 104. [0079] FIG. 4B is an isometric side view of two arms 442b, 444b and a wedge 432b of an attachment portion 400b of a sensor unit, according to an embodiment. Unless otherwise noted, the attachment portion 400b may include any aspect of the attachment portion 400a. Rather than the set screw 432a of the attachment portion 400a, the attachment portion 400b may include the wedge 432b extending through the outer ring 430a to contact and/or extend between the two arms 442b, 444b. The ring 430a, the two arms 442b, 444b, and the wedge 432b of the attachment portion 400b may replace the ring 230 of the sensor unit 202, and the shaft 228 and/or the release slot 232 of the sensor unit 202 may be absent from the sensor housing used with the attachment portion 400b.
[0080] The wedge 432b may be secured or inserted through the outer ring 430a. The wedge may be selectively movable and include a narrow distal end (e g., tip) sized to fit between the two arms 442b, 444b. As the wedge 432b is pushed inward, the wedge spreads the two arms 442b, 444b further apart. Thus, the two arms 442b, 444b may be partially positioned within the hole 234 in the abutment and the wedge 432b may be used to secure the two arms 442b, 444b, and the sensor housing, to the abutment 104. For example, the two arms 442b. 444b may be inserted into the hole 234 of the abutment 104. and the wedge 432b may be pushed inward. As the wedge 432b is pushed inward between the two arms 442b, 444b, the wedge 432b forces the two arms 442b, 444b outward, away from one another. The wedge 432b may be pushed until the two arms 442b, 444b are spaced apart in the hole 234 and contacting portions of the abutment 104 defining the hole 234 sufficient to secure the two arms 442b, 444b and the sensor housing to the abutment 104. In some embodiments, the attachment portion 400b may include a lock configured to hold the wedge 432b in this position that spreads the arms 442b, 444b apart sufficient to secure the arms 442b, 444b to the abutment 104. In some embodiments, the hole 234 in the abutment 104 may include a star-shaped hole, and each of the two arms 442b, 444b may be secured within a different point of the star to more effectively secure the two arms 442b, 444b to the abutment 104.
[0081] FIG. 4C is an isometric side view of two arms 442c, 444c and a tapered head 433c of a detent element such as a set screw 432c of an attachment portion 400c of a sensor unit, according to an embodiment. Unless otherwise noted, the attachment portion 400c may include any aspect of the attachment portion 400a or 400b. Rather than the set screw 432a of the attachment portion 400a, the attachment portion 400c may include the set screw 432c having the tapered head 433c extending through the outer ring 430a to contact and/or extend between the two arms 442c, 444c. The ring 430a, the two arms 442c, 444c, and the set screw 432c having the tapered head 433c of the attachment portion 400c may replace the ring 230 of the sensor unit 202. and the shaft 228 and/or the release slot 232 of the sensor unit 202 may be absent from the sensor housing used with the attachment portion 400c.
[0082] In some embodiments, the set screw 432c may be threadedly secured or securable to the outer ring 430a. The set screw 432c may be selectively adjustable and, when the outer ring 430a is positioned on the top portion of the abutment 104, may be rotated to extend the set screw 432a further into the opening 431a of the outer ring 430a to drive the tapered end 433c between the two arms 442c, 444c. As the set screw 432c is extended further into the opening 431c of the ring 430c while betw een the tw o arms 442c, 444c. the set screw 432c may spread apart the two arms 442c, 444c until at least a portion of the two arms 442c, 444c contact portions of the abutment 104 defining the hole 234 in the abutment 104. For example, the set screw 432c may press the two arms 442c, 444c further apart until at least a portion (e.g, the terminating end region) of each of the two arms 442c, 444c fit within the different points of a star-shaped hole in the abutment 104. This expansion or separation of the two arms 442c, 444c in the hole 234 causes the two arms 442c, 444c to contact portions of the abutment 104 defining the hole 234 (e.g., points of the star in a star-shaped hole), thereby securing the two arms 442c, 444c in the hole 234, and securing the sensor housing to the abutment 104.
[0083] FIG. 4D is a partial cross-sectional side view of an attachment portion 400d of a sensor unit 402d secured to an abutment 104, according to an embodiment. In some embodiments, the sensor unit 402d includes a lower portion 426d of the sensor housing and an upper portion 412d encapsulating the sensor 216 and the motor 220. The upper portion 412d may include a smaller diameter or width than the lower portion 426d of the sensor housing of the sensor unit 402d. In some embodiments, with the exception of the attachment portion 400d, the sensor unit 402d may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212.
[0084] The attachment portion 400d may utilize a combination of a central attachment and an outer attachment to the abutment 104. In some embodiments, the attachment portion 400d of the sensor housing includes a complete or segmented outer ring, an arm or shaft 444d, and a detent element such as a set screw 432d extending through the a second region 430d of the complete or segmented outer ring to contact the shaft 444d. The ring, the shaft 444d, and the set screw 432d may replace the ring 230, the shaft 228, and/or the release slot 232 of the sensor unit 202. [0085] The outer ring may include a first region 430d’ configured to position around a portion of the periphery of the abutment 104 and the second region 430d configured to position on top of the abutment 104. The shaft 444d may be positioned to extend into the hole 234 of the abutment 104 when the first region 430d’ is disposed around the portion of the periphery' of the abutment 104 and the second region 430d is disposed on top of the abutment 104.
[0086] The second region 430d of the ring may extend from the bottom surface 427d of the lower portion 426d of the sensor housing to any distance described above in relation to the seating ring 230. The first region 430d‘ and the shaft 444d extend further from the bottom surface 427 than the first region 430d of the ring such that the shaft 444d may- extend at least partially into the hole 234. The first region 430d’ of the ring may extend around a periphery of the abutment 104 while the second region 430d of the ring sits atop the abutment 104.
[0087] The set screw 432d may be threadedly secured or securable to the second region 430d of the ring that is positioned to be disposed on top of the abutment 104. The set screw 432d is selectively adjustable and. when the shaft 444d is disposed within the hole 234 of the abutment 104, the set screw 432d may be rotated to extend the set screw 432d further against the shaft 444d. As the set screw 432d is extended further against the shaft 444d, the set screw 432d may force the shaft 444 and the first region 430d’ of the outer ring closer together to clamp a portion of the abutment 104 therebetween. The set screw 432d may then be adjusted to tighten the abutment 104 between the shaft 444d and the first region 430d’ of the outer ring, thereby securing the abutment 104 to the attachment portion 400d and the sensor housing.
[0088] FIG. 4E is a partial cross-sectional side view of an attachment portion 400e of a sensor unit 402e secured to an abutment 104. according to an embodiment. In some embodiments, the sensor unit 402e includes a lower portion 426e of the sensor housing and an upper portion 412e encapsulating the sensor 216 and the motor 220. The upper portion 412e may include a smaller diameter or width than the lower portion 426e of the sensor housing of the sensor unit 402e. In some embodiments, with the exception of the attachment portion 400e. the sensor unit 402e may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212.
[0089] The attachment portion 400e may utilize a central attachment to the abutment 104. In some embodiments, the attachment portion 400e includes a complete or segmented outer ring 43 Oe, two arms 442e, 444e within the ring 43 Oe, and a detent element such as a set screw 432e extending through the outer ring 430e to contact a first arm 444e of the two arms 442e. 444e. The ring 430e, the two arms 442e, 444e, and the set screw 432e may replace the ring 230, the shaft 228, and/or the release slot 232 of the sensor unit 202.
[0090] The outer ring 430e (whether complete or segmented) may be sized to rest on top of the abutment 104 rather than receive the top portion of the abutment 104 within the ring 43 Oe. In some embodiments, the two arms 442e, 444e may be flexible and positioned or spaced such that the two arms 442e, 444e fit within the hole of the abutment unless spread apart by the set screw 432e.
[0091] The set screw 432e may extend through the outer ring 430e, and may be threadedly secured or securable through a first arm 444e. The set screw 432e is selectively adjustable and. when the outer ring 430e is positioned on the top portion of the abutment 104, the set screw 432e may be rotated a first direction to spread the two arms 442e, 444e apart and/or rotated a second direction to bring the two arms 442e, 444e closer together. Once the two arms 442e, 444e are at least partially disposed in the hole 234 of the abutment 104, the set screw 432e may be rotated to spread the two arms 442e, 444e further apart, thereby allowing the portions of the two arms 442e, 444e disposed in the hole 234 to expand or spread apart in the hole 234. This spreading apart or expansion in the hole 234 causes the two arms 442e, 444e to contact portions of the abutment defining the hole 234, thereby securing the two arms 442e, 444e in the hole 234, and securing the sensor unit 402e to the abutment 104. In some embodiments, the hole 234 in the abutment 104 may include a starshaped hole, and each of the two arms 442e, 444e may be secured within a different point of the star to more effectively secure the two arms 442e, 444e to the abutment 104.
[0092] FIG. 5A is a partial cross-sectional side view of an attachment portion 500a of a sensor unit 502a secured to an abutment 104, and FIG. 5B is an isometric bottom view of the attachment portion 500a of the sensor unit 502a of FIG. 5A, according to an embodiment. In some embodiments, the sensor unit 502a includes a lower portion 526a of the sensor housing and an upper portion 512a encapsulating the sensor 216 and the motor 220. The upper portion 512a may include a smaller diameter or width than the lower portion 526a of the sensor housing of the sensor unit 502a. In some embodiments, with the exception of the attachment portion 500a, the sensor unit 502a may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212.
[0093] The attachment portion 500a may include a plurality of tabs or clips 530a extending from the bottom surface 527 of the lower portion 526a of the sensor housing. The plurality of clips 530a may extend from the bottom surface 527 any distance provided above in relation to the seating ring 230. The plurality of clips 530a may include two, three, four, or more pins positioned substantially equal distance around an axis a. The plurality of clips 530a may include a flexible and/or resilient material. In some embodiments, the plurality of clips 530 and/or the lower portion 526a of the sensor housing may include a plastic material.
[0094] The plurality of clips 530a may be positioned to form a segmented ring 531 around the axis a having a diameter di. The diameter di of the segment ring 531 including the plurality of clips 530a is less than a diameter d2 of the upper region of the abutment 204, according to an embodiment. Accordingly, when the attachment portion 500a is positioned on the abutment 204, the plurality of clips 530a may form an interference or press fit with the upper region of the abutment 104 effective to attach the attachment portion 500a and the sensor unit 502a to the abutment 104.
[0095] The attachment portion 500a also may include a positioning shaft or pin 544 extending from the bottom surface 527 of the lower portion 526 of the sensor housing. The pin 544 may be positioned on the axis a to align with the hole 234 of the abutment 104 when the attachment portion 500a is secured to the abutment 104 (e.g, the pin 544 may be central or axially positioned relative to the plurality of clips 530a). The pin 544 may extend a shorter distance from the bottom surface 527 than the plurality of clips 530a.
[0096] FIG. 5C is a side view of a sensor unit 502c having an attachment portion 500c secured to the abutment 104, according to an embodiment. In some embodiments, the sensor unit 502c includes a lower portion 526c of the sensor housing and the upper portion 512a encapsulating the sensor 216 and the motor 220. In some embodiments, with the exception of the attachment portion 500c, the sensor unit 502c may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212. [0097] Unless otherwise noted, the attachment portion 500c may include any aspect of the attachment portion 500a. The attachment portion 500c may include a plurality of clips 530c. In some embodiments, the plurality of clips 530c are compliant and/or angle inwards towards the axis a as the plurality of clips 530c extend from the bottom surface 527. In some embodiments, the plurality of clips 530c may taper as the plurality of clips 530c extend from the bottom surface 527. The tapering of the plurality of clips 530c allows the attachment portion 500c to attach to multiple sizes of abutments 104 (e.g., abutments 104 having a variety of diameters).
[0098] FIG. 5D is a side view of a sensor unit having an attachment portion 500d secured to the abutment 104, according to an embodiment. In some embodiments, the sensor unit 502d includes a lower portion 526d of the sensor housing and the upper portion 512a encapsulating the sensor 216 and the motor 220. In some embodiments, with the exception of the attachment portion 500d, the sensor unit 502d may include a similar configuration to the sensor unit 202 including the sensor housing 226 and the cover 212. [0099] Unless otherwise noted, the attachment portion 500d may include any aspect of the attachment portion 500a. 500c. The attachment portion 500d may include a plurality of clips 530d. In some embodiments, one or more (e.g., all) of the plurality of clips 530d includes one or more teeth 532d on an inward facing surface of the one or more of the plurality7 of clips 530d. The one or more teeth 532d may be configured to grip the abutment 104 to facilitate attachment of the attachment portion 500d to the abutment 104. In some embodiments, the one or more teeth 532 allows the attachment portion 500d to attach to multiple sizes of abutments 104 (e g., abutments 104 having a variety of diameters).
[00100] FIG. 6 is a flow diagram of a method 600 of securing a sensor unit to an abutment, according to an embodiment. The method includes providing 605 the sensor unit. The sensor unit may include any of the sensor units disclosed herein. The sensor unit may include a sensor housing having an attachment portion, a motor secured to the sensor housing and configured to exert a lateral force on the implant, and a sensor secured to the sensor housing. The sensor may be configured to measure at least one of vibration or motion of the implant secured responsive to the mechanical force exerted by the motor, and configured to communicate with a control unit. The method includes detachably securing 610 the attachment portion of the sensor housing to an abutment.
[00101] In some embodiment, detachably securing 610 the attachment portion of the sensor housing to an abutment includes press-fitting a shaft extending from a first surface region of the sensor housing into a hole in the abutment, and press-fitting a portion of the abutment within a seating ring protruding from the first surface region and extending at least partially about or around the shaft.
[00102] In some embodiments, detachably securing 610 the attachment portion of the sensor housing to an abutment includes creating three or more contact points between the atachment portion and the abutment effective to selectively secure the attachment portion to the abutment.
[00103] More specifically, the one or more members of the atachment portion may include: a ring that is asymmetric and/or oval and defines an opening having a first region with a smaller radius and a second region with a larger radius that is greater than the smaller radius; and a detent element extending through the ring proximate to the second region. Creating three or more contact points between the atachment portion and the abutment effective to selectively secure the atachment portion to the abutment may include: inserting a portion of the abutment into the opening of the ring being sized such that the ring contacts the abutment at two contact points proximate to the first region; and adjusting the detent element to contact the abutment at a third contact point substantially opposite to the first region when the portion of the abutment is received within the opening.
[00104] In some embodiments, the one or more portions of the atachment portion include: a ring that is discontinuous and/or segmented, the ring including a first arced segment and a second segment; and a detent element extending through the second segment. Creating three or more contact points between the atachment portion and the abutment effective to selectively secure the atachment portion to the abutment may include inserting a portion of abutment between the first arced segment and the second segment such that the first arced segment contacts the abutment at two contact points of the first arced segment; and adjusting the detent element to contact the abutment at a third contact point substantially opposite to the first arced segment.
[00105] In some embodiments, the one or more members of the atachment portion include: a ring that is discontinuous and/or segmented, the ring including a first arced segment and a second segment; and a biased plunger extending through the second segment, the biased plunger having a head biased inwardly towards the first arced segment.
Creating three or more contact points between the atachment portion and the abutment effective to selectively secure the atachment portion to the abutment may include: inserting a portion of the abutment between the first arced segment and the second segment such that the first arced segment contacts the abutment at two contact points of the first segment; and the biased plunger biasing the head inwards to contact the abutment at a third contact point substantially opposite to the first arced segment.
[00106] In some embodiment, the one or more members of the atachment portion include a plurality of clips extending from a first surface region of the sensor housing and positioned around an axis to form a segmented ring having a first diameter that is less than a diameter of the abutment, the plurality of clips including at least three clips. Creating three or more contact points between the attachment portion and the abutment effective to selectively secure the attachment portion to the abutment may include press-fitting a portion of the abutment within the segmented ring between the plurality of clips. The method 600 may further comprise inserting a positioning pin extending from the first surface region on the axis into a hole in the abutment. The plurality of clips may be compliant and/or angled inwards towards the axis as the plurality of clips extend from the first surface region. The plurality of clips may taper as the plurality of clips extend from the first surface region. At least one clip of the plurality of clips may include one or more teeth on an inward facing surface of that least one clip.
[00107] In some embodiments, detachably securing 610 the attachment portion of the sensor housing to an abutment includes positioning one or more members of the attachment portion on a top surface of the abutment and positioning one or more members of the attachment portion within a hole of the abutment. [00108] More specifically, detachably securing the attachment portion of the sensor housing to an abutment may include: positioning a ring on the top surface of the abutment, the ring being continuous or discontinuous and extending from a first surface region of the sensor housing; and adjusting a detent element extending through the ring inward to contact at least one arm of two arms extending from the first surface region of the sensor housing and directing the two arms closer together, the two arms being spaced apart such that the two arms do not fit within the hole of the abutment until the detent element contacts the at least one arm of the two arms and directs the two arms closer together.
[00109] In some embodiments, detachably securing the attachment portion of the sensor housing to an abutment may include: positioning a ring on the top surface of the abutment, the ring being continuous or discontinuous and extending from a first surface region of the sensor housing; inserting at least a portion of two arms extending from the first surface region of the sensor housing into the hole of the abutment; and extending a wedge or a detent element having a tapered head inward through the ring and towards a center of the ring between the two arms to spread the two arms apart from one another to secure at least the portion of the two arms in the hole of the abutment.
[00110] In some embodiments, detachably securing the attachment portion of the sensor housing to an abutment may include: positioning a ring on the top surface of the abutment, the ring extending from a first surface region of the sensor housing: and adjusting a detent element extending through the ring and a first arm of two arms extending from the first surface region of the sensor housing to spread the two arms further apart to secure a portion of the two arms in the hole of the abutment by contacting a second arm of the two arms.
[00111] In some embodiments, detachably securing the attachment portion of the sensor housing to an abutment may include: positioning a first region of a ring around a portion of the periphery' of the abutment; positioning a second region of the ring on the top surface of the abutment; inserting an arm of the attachment portion at least partially into the hole, the arm being positioned between the first region and the second region of the ring; and adjusting a detent element extending through the second region to contact the arm and direct the arm towards the first region effective to clamp a portion of the abutment between the arm and the first region.
[00112] Acts of the method 600 are for illustrative purposes. For example, the acts of the method 600 may be performed in different orders, split into multiple acts, modified, supplemented, or combined. Any of the acts of the method 600 may include using any of the sensor units or attachment portions disclosed herein. [00113] In some embodiments, a method of analyzing stability of an implant is disclosed. The method may include securing a sensor unit to an abutment secured to an implant as described above. The method also may include with a control unit, selecting a tooth position of the implant, selecting a ty pe of the implant, selecting a type of the abutment, directing a motor of the sensor unit to exert a mechanical and/or lateral force on the implant, receiving acceleration of the implant measure by a sensor of the sensor unit; and determining a stability of the implant using a mechanics-base prediction model.
[00114] As used herein, the term “about” or “substantially” refers to an allowable variance of the term modified by “about” by ±10% or ±5%. Further, the terms “less than,” “or less,” “greater than”, “more than,” or “or more” include as an endpoint, the value that is modified by the terms “less than,” “or less,” “greater than,” “more than,” or “or more.”
[00115] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiment disclosed herein are for purposes of illustration and are not intended to be limiting.

Claims

CLAIMS What is claimed is:
1. A sensor unit for use with a dental implant stability analyzing system, the sensor unit comprising: a sensor housing having an attachment portion configured to detachably secure the sensor housing to an abutment; a motor secured to the sensor housing and configured to exert a lateral force on the implant; and a sensor secured to the sensor housing, the sensor being configured to measure at least one of vibration, motion, or acceleration of the implant secured responsive to a mechanical force exerted by the motor, and further configured to communicate with a control unit.
2. The sensor unit of claim 1, wherein the attachment portion includes a shaft extending from a first surface region of the sensor housing, a seating ring protruding from the first surface region and extending at least partially about or around the shaft, and a release slot extending from the seating ring to a periphery of the housing, wherein the shaft is threadless and configured to be press fit into a hole of the abutment secured to the implant to detachably secure the sensor unit to the abutment.
3. The sensor unit of claim 2, wherein the shaft includes one of a circular, hexagonal, or hexalobular cross-sectional shape configured to be complementary to the hole in the abutment.
4. The sensor unit of claim 1. wherein the attachment portion includes one or more members configured to create three or more contact points between the attachment portion and the abutment effective to selectively secure the attachment portion to the abutment.
5. The sensor unit of claim 4, wherein the one or more members of the attachment portion include: a ring that is asymmetric and/or oval and defines an opening having a first region with a smaller radius and a second region with a larger radius that is greater than the smaller radius, the opening and the ring being sized to receive a portion of the abutment within the opening such that the ring contacts the abutment at two contact points proximate to the first region when the portion of the abutment is received within the opening, wherein the ring is substantially continuous; and a detent element extending through the ring proximate to the second region, the detent element being selectively adjustable to contact the abutment at a third contact point substantially opposite to the first region when the portion of the abutment is received within the opening.
6. The sensor unit of claim 4, wherein the one or more members of the attachment portion include: a ring that is discontinuous and/or segmented, the ring including a first arced segment and a second segment, the first arced segment and the second segment being spaced to receive a portion of the abutment therebetween such that the first arced segment contacts the abutment at tw o contact points of the first arced segment when the portion of the abutment is received within the opening: and a detent element extending through the second segment, the detent element being selectively adjustable to contact the abutment at a third contact point substantially opposite to the first arced segment when the portion of the abutment is received within the opening.
7. The sensor unit of claim 4, wherein the one or more members of the attachment portion include: a ring that is discontinuous and/or segmented, the ring including a first arced segment and a second segment, the first arced segment and the second segment being spaced to receive a portion of the abutment therebetween such that the first arced segment contacts the abutment at two contact points of the first segment when the portion of the abutment is received within the opening; and a biased plunger extending through the second segment, the biased plunger having a head biased inwardly towards the first arced segment to contact the abutment at a third contact point substantially opposite to the first arced segment when the portion of the abutment is received within the opening.
8. The sensor unit of claim 4, wherein the one or more members of the attachment portion include: a plurality of clips extending from a first surface region of the sensor housing and positioned around an axis to form a segmented ring having a first diameter that is less than a diameter of the abutment, the plurality of clips including at least three clips.
9. The sensor unit of claim 8, wherein the attachment portion further comprises a positioning pin extending from the first surface region on the axis to aligned with a hole in the abutment when the plurality of clips secure the attachment portion to the abutment.
10. The sensor unit of claim 8, wherein the plurality of clips are compliant and/or angled inwards towards the axis as the plurality of clips extend from the first surface region.
11. The sensor unit of claim 8, wherein the plurality of clips taper as the plurality of clips extend from the first surface region.
12. The sensor unit of claim 8, wherein at least one clip of the plurality of clips includes one or more teeth on an inward facing surface of that least one clip.
13. The sensor unit of claim 1, wherein the attachment portion includes one or more members configured to be positioned on a top surface of the abutment and one or more members configured to be positioned within a hole of the abutment.
14. The sensor unit of claim 13, wherein the one or more members of the attachment portion include: a ring that includes a first region sized and shaped to extend around a portion of a periphery of the abutment, and a second region positioned and sized to be disposed on the top surface of the abutment; an arm positioned between the first region and the second region of the ring, the arm being sized and positioned to be disposed partially in the hole of the abutment when the first region is disposed around the portion of the periphery of the abutment and the second region is disposed on the top surface of the abutment; and a detent element extending through the second region and selectively adjustable to contact the arm when the arm is at least partially disposed in the hole, and direct the arm towards the first region effective to clamp a portion of the abutment between the arm and the first region.
15. The sensor unit of claim 13, wherein the one or more members of the attachment portion include: a ring that is continuous or discontinuous extending from a first surface region of the sensor housing, the ring being sized to be positioned on the top surface of the abutment; a detent element extending through the ring and adjustable to extend inward towards a center of the ring and outwards away from the center of the ring; and two arms extending from the first surface region of the sensor housing and positioned to contact the detent element as the detent element is extended towards the center of the ring, the two arms being spaced apart such that the two arms do not fit within the hole of the abutment until the detent element contacts at least one arm of the two arms and directs the two arms closer together.
16. The sensor unit of claim 13, wherein the one or more members of the attachment portion include: a ring that is continuous or discontinuous extending from a first surface region of the sensor housing, the ring being sized to be positioned on the top surface of the abutment; a wedge or a detent element having a tapered head extending through the ring and adjustable to extend inward towards a center of the ring and outwards away from the center of the ring; and two arms extending from the first surface region of the sensor housing and positioned to receive the wedge or the detent element between the two arms as the wedge or the detent element is extended towards the center of the ring, the two arms being spaced apart such that the two arms fit within the hole of the abutment and receiving the wedge or the detent element spreads the two arms apart to secure at least a portion of the two arms in the hole of the abutment.
17. The sensor unit of claim 13, wherein the one or more members of the attachment portion include: a ring extending from a first surface region of the sensor housing and sized to be positioned on the top surface of the abutment; two arms extending from the first surface region of the sensor housing and disposed between two regions of the ring; and a detent element extending through the ring and a first arm of the two arms, the detent element being adjustable to spread the two arms further apart to secure a portion of the two arms in the hole of the abutment by contacting a second arm of the two arms, or allow the two arms to move closer together by removing contact from the second arm.
18. The sensor unit of claim 1 , further comprising a cover secured to the sensor housing.
19. The sensor unit of claim 18, wherein the sensor unit is reusable, the sensor housing and the cover include one or more of a titanium alloy, aluminum, aluminum alloy, steel, and/or stainless steel, and the motor and the sensor are selectively removable from the sensor housing.
20. The sensor unit of claim 1, further comprising an implant stability analyzing system including one or more electronic devices having: a control unit operably connected to the sensor unit, the control unit configured to communicate with the sensor unit, direct the motor of the sensor unit to exert a mechanical force and/or a lateral force on the implant, and receive the at least one of the vibration, the motion, or the acceleration of the implant measured by the sensor of the sensor unit; and a module configured to communicate with the control unit, receive the at least one of the vibration, the motion, or the acceleration measured by the sensor of the sensor unit, and determine a stability of the implant.
21. The sensor unit of claim 20, wherein the one or more electronic devices include a single electronic device include the control unit and the module configured to communicate with the control unit.
22. A method of securing a sensor unit of a dental implant stability analyzing system to an abutment, the method comprising: providing the sensor unit, comprising: a sensor housing having an attachment portion; a motor secured to the sensor housing and configured to exert a lateral force on the implant; and a sensor secured to the sensor housing, the sensor being configured to measure at least one of vibration or motion of the implant secured responsive to the mechanical force exerted by the motor, and configured to communicate with a control unit; and detachably securing the attachment portion of the sensor housing to an abutment.
23. The method of claim 22. wherein detachably securing the attachment portion of the sensor housing to an abutment includes at least one of: press-fitting a shaft extending from a first surface region of the sensor housing into a hole in the abutment; or press-fitting a portion of the abutment within a seating ring protruding from the first surface region and extending at least partially about or around the shaft.
24. The method of claim 22, wherein detachably securing the attachment portion of the sensor housing to an abutment includes creating three or more contact points between the attachment portion and the abutment effective to selectively secure the attachment portion to the abutment.
25. The method of claim 24, wherein: the one or more members of the attachment portion include: a ring that is asymmetric and/or oval and defines an opening having a first region with a smaller radius and a second region with a larger radius that is greater than the smaller radius; a detent element extending through the ring proximate to the second region; and creating three or more contact points between the attachment portion and the abutment effective to selectively secure the attachment portion to the abutment includes: inserting a portion of the abutment into the opening of the ring being sized such that the ring contacts the abutment at two contact points proximate to the first region; and adjusting the detent element to contact the abutment at a third contact point substantially opposite to the first region when the portion of the abutment is received within the opening.
26. The method of claim 24, wherein: the one or more portions of the attachment portion include: a ring that is discontinuous and/or segmented, the ring including a first arced segment and a second segment; and a detent element extending through the second segment; and creating three or more contact points between the attachment portion and the abutment effective to selectively secure the attachment portion to the abutment includes: inserting a portion of abutment between the first arced segment and the second segment such that the first arced segment contacts the abutment at two contact points of the first arced segment: and adjusting the detent element to contact the abutment at a third contact point substantially opposite to the first arced segment.
27. The method of claim 24, wherein: the one or more members of the attachment portion include: a ring that is discontinuous and/or segmented, the ring including a first arced segment and a second segment; and a biased plunger extending through the second segment, the biased plunger having a head biased inwardly towards the first arced segment; and creating three or more contact points between the attachment portion and the abutment effective to selectively secure the attachment portion to the abutment includes: inserting a portion of the abutment between the first arced segment and the second segment such that the first arced segment contacts the abutment at two contact points of the first segment; and the biased plunger biasing the head inwards to contact the abutment at a third contact point substantially opposite to the first arced segment.
28. The method of claim 24, wherein: the one or more members of the attachment portion include a plurality of clips extending from a first surface region of the sensor housing and positioned around an axis to form a segmented ring having a first diameter that is less than a diameter of the abutment, the plurality of clips including at least three clips; and creating three or more contact points between the attachment portion and the abutment effective to selectively secure the attachment portion to the abutment includes press-fitting a portion of the abutment within the segmented ring between the plurality of clips.
29. The method of claim 28, further comprising inserting a positioning pin extending from the first surface region on the axis into a hole in the abutment.
30. The method of claim 28, wherein the plurality of clips are compliant and/or angled inwards towards the axis as the plurality’ of clips extend from the first surface region.
31. The method of claim 28, wherein the plurality of clips taper as the plurality of clips extend from the first surface region.
32. The method of claim 28, wherein at least one clip of the plurality’ of clips includes one or more teeth on an inward facing surface of that least one clip.
33. The method of claim 22. wherein detachably securing the attachment portion of the sensor housing to an abutment includes positioning one or more members of the attachment portion on a top surface of the abutment and positioning one or more members of the attachment portion w ithin a hole of the abutment.
34. The method of claim 33. wherein detachably securing the attachment portion of the sensor housing to an abutment includes: positioning a ring on the top surface of the abutment, the ring being continuous or discontinuous and extending from a first surface region of the sensor housing; and adjusting a detent element extending through the ring inward to contact at least one arm of two arms extending from the first surface region of the sensor housing and directing the two arms closer together, the two arms being spaced apart such that the two arms do not fit yvithin the hole of the abutment until the detent element contacts the at least one arm of the two arms and directs the tw o arms closer together.
35. The method of claim 33. wherein detachably securing the attachment portion of the sensor housing to an abutment includes: positioning a ring on the top surface of the abutment, the ring being continuous or discontinuous and extending from a first surface region of the sensor housing; inserting at least a portion of two arms extending from the first surface region of the sensor housing into the hole of the abutment; and extending a wedge or a detent element having a tapered head inward through the ring and towards a center of the ring between the two arms to spread the two arms apart from one another to secure at least the portion of the two arms in the hole of the abutment.
36. The method of claim 33, wherein detachably securing the attachment portion of the sensor housing to an abutment includes: positioning a ring on the top surface of the abutment, the ring extending from a first surface region of the sensor housing; and adjusting a detent element extending through the ring and a first arm of two arms extending from the first surface region of the sensor housing to spread the two arms further apart to secure a portion of the two arms in the hole of the abutment by contacting a second arm of the two arms.
37. The method of claim 33. wherein detachably securing the attachment portion of the sensor housing to an abutment includes: positioning a first region of a ring around a portion of the periphery' of the abutment; positioning a second region of the ring on the top surface of the abutment; inserting an arm of the attachment portion at least partially into the hole, the arm being positioned between the first region and the second region of the ring; and adjusting a detent element extending through the second region to contact the arm and direct the arm towards the first region effective to clamp a portion of the abutment between the arm and the first region.
38. The method of claim 22, further comprising: with a control unit, selecting a tooth position of the implant; with the control unit, selecting a type of the implant; with the control unit, selecting a type of the abutment; with the control unit, directing a motor of the sensor unit to exert a mechanical and/or lateral force on the implant; with the control unit, receiving acceleration of the implant measure by a sensor of the sensor unit; and with the control unit, determining a stability of the implant using a mechanics-base prediction model.
PCT/US2024/020659 2023-03-27 2024-03-20 Sensor units for use with a medical implant stability analyzing system, and related systems and methods WO2024206009A1 (en)

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US9949644B2 (en) * 2013-09-03 2018-04-24 Fourth Military Medical University of Chinese People's Liberation Army Torsional vibration resonance frequency measurement method for estimating stability of dental implant and novel amplitude transformer
WO2016204684A1 (en) * 2015-06-18 2016-12-22 Osstell Ab Implant stability measuring device and method
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