Methods and Devices to Measure Angular Stiffness of Dental and Medical Implants
20240293214 ยท 2024-09-05
Inventors
- I-Yeu SHEN (Seattle, WA, US)
- Yifeng Liu (Seattle, WA, US)
- Darwin S. Wood (Seattle, WA, US)
- Weiwei Xu (Seattle, WA, US)
Cpc classification
International classification
A61C19/04
HUMAN NECESSITIES
A61C8/00
HUMAN NECESSITIES
Abstract
The present disclosure provides a device for measuring a stability of an implant system. The device includes a housing configured to be positioned adjacent the implant system. The device also includes an actuator coupled to the housing. The actuator is configured to vibrate the implant system when actuated. The device also includes a motion sensor coupled to the housing, and a controller in communication with the motion sensor and the actuator. The controller includes at least one processor, and data storage including program instructions stored thereon that when executed by the at least one processor, cause the controller to perform functions including: (i) receiving motion data from the motion sensor when the actuator is actuated, and (ii) determining an angular stiffness of the implant system based on the motion data.
Claims
1. A device for measuring a stability of an implant system, the device comprising: a housing configured to be positioned adjacent the implant system; an actuator coupled to the housing, wherein the actuator is configured to vibrate the implant system when actuated; a motion sensor coupled to the housing; and a controller in communication with the motion sensor and the actuator, wherein the controller includes at least one processor, and data storage including program instructions stored thereon that when executed by the at least one processor, cause the controller to perform functions including: receiving motion data from the motion sensor when the actuator is actuated; and determining an angular stiffness of the implant system based on the motion data.
2. (canceled)
3. The device of claim 1, wherein the implant system includes an implant implanted in a bone and an abutment coupled to the implant, wherein at least a portion of the abutment is exposed and not directly coupled to the bone, wherein the housing includes a cutout, and wherein the abutment is configured to be positioned at least partially within the cutout.
4. (canceled)
5. The device of claim 1, wherein the implant system includes a longitudinal axis extending from a first surface to a second surface opposite the first surface, wherein the implant system includes a second axis that is perpendicular to the longitudinal axis, and wherein the angular stiffness corresponds to a stiffness of a rotation of the implant system with respect to the second axis.
6. The device of claim 1, wherein the controller is further configured to: provide a binary indication of whether or not the implant system is stable based on the determined angular stiffness of the implant system.
7. The device of claim 1, wherein the controller is further configured to: provide a notification of a degree of stability of the implant system based on the determined angular stiffness of the implant system.
8. (canceled)
9. The device of claim 1, wherein the actuator is configured to vibrate at a first frequency which is measured by the motion sensor to define a first motion data, wherein the actuator is configured to vibrate at a second frequency which is measured by the motion sensor to define a second motion data, and wherein the controller determines the angular stiffness of the implant system based on both the first motion data and the second motion data.
10. The device of claim 1, wherein the actuator comprises a first actuator, the device further comprising: a second actuator coupled to the housing, wherein the second actuator is configured to vibrate the implant system when actuated, wherein the first actuator is configured to vibrate at a first frequency which is measured by the motion sensor to define a first motion data, wherein the second actuator is configured to vibrate at a second frequency which is measured by the motion sensor to define a second motion data, and wherein the controller determines the angular stiffness of the implant system based on both the first motion data and the second motion data.
11. (canceled)
12. (canceled)
13. (canceled)
14. (canceled)
15. (canceled)
16. The device of claim 1, further comprising: one or more bypass capacitors positioned between the motion sensor and the controller.
17. The device of claim 1, wherein the motion data comprises acceleration data, and wherein determining the angular stiffness of the implant system based on the acceleration data comprises: applying a nonlinear regression algorithm to extract a frequency ? and an amplitude A.sub.0 of the motion data; determining an experimentally measured flexibility (C.sub.AB).sub.exp of the implant system using the equation
18. A device for measuring a stability of an implant system, the device comprising: a housing configured to be positioned adjacent the implant system; an actuator coupled to the housing, wherein the actuator is configured to vibrate the implant system when actuated; a motion sensor coupled to the housing; and a controller in communication with the motion sensor and the actuator, wherein the controller includes at least one processor, and data storage including program instructions stored thereon that when executed by the at least one processor, cause the controller to perform functions including: receiving motion data from the motion sensor when the actuator is actuated; and transmitting the motion data to a user interface, wherein the user interface is configured to determine an angular stiffness of the implant system based on the motion data.
19. (canceled)
20. The device of any one of claims 18-19, wherein the implant system includes an implant implanted in a bone and an abutment coupled to the implant, wherein at least a portion of the abutment is exposed and not directly coupled to the bone, wherein the housing includes a cutout, and wherein the abutment is configured to be positioned at least partially within the cutout.
21. (canceled)
22. The device of claim 18, wherein the implant system includes a longitudinal axis extending from a first surface to a second surface opposite the first surface, wherein the implant system includes a second axis that is perpendicular to the longitudinal axis, and wherein the angular stiffness corresponds to a stiffness of a rotation of the implant system with respect to the second axis.
23. The device of claim 18, wherein the user interface is further configured to: provide a binary indication of whether or not the implant system is stable based on the determined angular stiffness of the implant system.
24. The device of claim 18, wherein the user interface is further configured to: provide a notification of a degree of stability of the implant system based on the determined angular stiffness of the implant system.
25. (canceled)
26. The device of claim 18, wherein the actuator is configured to vibrate at a first frequency which is measured by the motion sensor to define a first motion data, wherein the actuator is configured to vibrate at a second frequency which is measured by the motion sensor to define a second motion data, and wherein the user interface determines the angular stiffness of the implant system based on both the first motion data and the second motion data.
27. The device of claim 18, wherein the actuator comprises a first actuator, the device further comprising: a second actuator coupled to the housing, wherein the second actuator is configured to vibrate the implant system when actuated, wherein the first actuator is configured to vibrate at a first frequency which is measured by the motion sensor to define a first motion data, wherein the second actuator is configured to vibrate at a second frequency which is measured by the motion sensor to define a second motion data, and wherein the user interface determines the angular stiffness of the implant system based on both the first motion data and the second motion data.
28. (canceled)
29. (canceled)
30. (canceled)
31. (canceled)
32. (canceled)
33. The device of claim 18, further comprising: one or more bypass capacitors positioned between the motion sensor and the controller.
34. The device of claim 18, wherein the motion data comprises acceleration data, and wherein determining the angular stiffness of the implant system based on the acceleration data comprises: applying a nonlinear regression algorithm to extract a frequency ? and an amplitude A.sub.0 of the motion data; determining an experimentally measured flexibility (C.sub.AB).sub.exp of the implant system using the equation
35. A method for measuring a stability of an implant system, the method comprising: positioning a device adjacent the implant system, wherein the device comprises (i) a housing, (ii) an actuator coupled to the housing, and (iii) a motion sensor coupled to the housing; actuating the actuator of the device to vibrate the implant system; determining, via the motion sensor, motion data of the implant system; and determining an angular stiffness of the implant system based on the motion data, wherein the motion data comprises acceleration data, and wherein determining the angular stiffness of the implant system based on the acceleration data comprises: applying an algorithm to extract a frequency ? and an amplitude A.sub.0 of the motion data; determining an experimentally measured flexibility (C.sub.AB).sub.exp of the implant system using the equation
36. The method of claim 35, wherein determining the angular stiffness of the implant system comprises: receiving, via a controller of the device, the motion data of the implant system; transmitting, via the controller, the motion data to a user interface; and determining, via the user interface, the angular stiffness of the implant system based on the motion data.
37. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0057] Example methods and systems are described herein. It should be understood that the words example, exemplary, and illustrative are used herein to mean serving as an example, instance, or illustration. Any embodiment or feature described herein as being an example, being exemplary, or being illustrative is not necessarily to be construed as preferred or advantageous over other embodiments or features. The example embodiments described herein are not meant to be limiting. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the Figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.
[0058] Furthermore, the particular arrangements shown in the Figures should not be viewed as limiting. It should be understood that other embodiments may include more or less of each element shown in a given Figure. Further, some of the illustrated elements may be combined or omitted. Yet further, an example embodiment may include elements that are not illustrated in the Figures.
[0059] As used herein, coupled means associated directly as well as indirectly. For example, a member A may be directly associated with a member B, or may be indirectly associated therewith, e.g., via another member C. It will be understood that not all relationships among the various disclosed elements are necessarily represented.
[0060] In
[0061] Unless otherwise indicated, the terms first, second, etc. are used herein merely as labels, and are not intended to impose ordinal, positional, or hierarchical requirements on the items to which these terms refer. Moreover, reference to, e.g., a second item does not require or preclude the existence of, e.g., a first or lower-numbered item, and/or, e.g., a third or higher-numbered item.
[0062] Reference herein to one embodiment or one example means that one or more feature, structure, or characteristic described in connection with the example is included in at least one implementation. The phrases one embodiment or one example in various places in the specification may or may not be referring to the same example.
[0063] As used herein, a system, apparatus, device, structure, article, element, component, or hardware configured to perform a specified function is indeed capable of performing the specified function without any alteration, rather than merely having potential to perform the specified function after further modification. In other words, the system, apparatus, structure, article, element, component, or hardware configured to perform a specified function is specifically selected, created, implemented, utilized, programmed, and/or designed for the purpose of performing the specified function. As used herein, configured to denotes existing characteristics of a system, apparatus, structure, article, element, component, or hardware which enable the system, apparatus, structure, article, element, component, or hardware to perform the specified function without further modification. For purposes of this disclosure, a system, apparatus, structure, article, element, component, or hardware described as being configured to perform a particular function may additionally or alternatively be described as being adapted to and/or as being operative to perform that function.
[0064] As used herein, with respect to measurements, about means +/?5%.
[0065] As used herein, with respect to measurements, substantially means +/?5%.
[0066] Generally, the present disclosure provides a device and methods of use thereof to measure the stability of a dental implant in a clinical environment.
[0067] Stability of a dental implant reflects quality of osseointegration between the implant and its surrounding bone. While many methods have been proposed to characterize implant stability, angular stiffness at the neck of the implant has been proven to be a rigorous and accurate measure. Nevertheless, fast and reliable measurements of the angular stiffness in a clinical environment is not yet available. The present disclosure provides a novel stability diagnostic device to measure the angular stiffness accurately in clinical environments. The device consists of a motion sensor, a controller, and a user interface. In the sensing unit, a housing attaches an actuator and a motion sensor to an abutment of an implant, whose angular stiffness is to be measured. The actuator vibrates at a frequency below the resonance frequency of the implant-bone-abutment system. Meanwhile, the motion sensor measures motion data of the abutment. The controller controls the actuator, reads the motion data, and transmits the motion data to the user interface via a wired or wireless link. The user interface may post-process the data and extract the angular stiffness through use of a finite element model and a nonlinear regression algorithm. The extracted angular stiffness may be benchmarked against that obtained via a force hammer and a laser Doppler vibrometer.
[0068]
[0069] The model 100 described above is a good compromise between practicality and complex clinical environments. On the one hand, this model is simple enough so that the angular stiffness can be found easily and reliably. On the other hand, the model 100 is versatile enough to accommodate complex scenarios encountered in clinical environments. For example, bones are anisotropic and their material properties vary widely among people. The bonding between the bone and the implant may not be perfect (e.g., partial bonding). All these scenarios can be incorporated by interpreting E as an equivalent Young's modulus of the model 100. This is, in essence, the concept of homogenization in micromechanics and in composite materials.
[0070] With the model 100 in
[0071] The first step is to obtain flexibility of the support-implant-abutment system experimentally. To do so, a harmonic force
is applied to point B on the abutment (as shown in
where X.sub.0 is the amplitude. Moreover, F.sub.0 and X.sub.0 are governed by linear elasticity because the system is quasi-static and the applied force is small.
[0072] In experiments, it is easier to measure acceleration instead. According to (2), acceleration a(t) at point A is
where the acceleration amplitude A.sub.0 is given as
Experimentally, if a known force F(t) in (1) is applied and the acceleration a(t) in (3) is measured, one can extract the flexibility or compliance (C.sub.AB).sub.exp from points B to A as
[0073] The second step is to determine the equivalent Young's modulus E based on the experimentally measured flexibility (C.sub.AB).sub.exp from (5). This can be done through use of finite element simulations and interpolation as follows. A finite element model is first created to mimic geometry and dimensions of the actual elastic support, implant, and abutment used in the test. For example, if an implant is placed in mandible and the flexibility (C.sub.AB).sub.exp is measured via an impression coping in a clinical environment, the finite element model will include the implant, the impression coping (as the abutment), and a homogeneous mandible whose equivalent Young's modulus E is to be determined. As another example,
[0074] One can use a trial-and-error process to extract the equivalent Young's modulus E as follows. When the block is trialed with a first Young's modulus E.sub.1, a unit force is applied to point B. The corresponding static deflection at point A (e.g., from a static finite element analysis) gives a first theoretical flexibility (C.sub.AB).sub.1. Next, the block is trialed with a second (and increased) Young's modulus E.sub.2 to obtain a second theoretical flexibility (C.sub.AB).sub.2. The trial-and-error process proceeds with ascending trialed Young's moduli E.sub.i, i=1, 2, 3, . . . , to obtain the corresponding theoretical flexibilities (C.sub.AB).sub.i, which are descending in numerical values. The trial-and-error process ends when the measured flexibility (C.sub.AB).sub.exp falls between two consecutive theoretical flexibilities (C.sub.AB).sub.i and (C.sub.AB).sub.i+1, i.e.,
The equivalent Young's modulus E is then obtained via linear interpolation as
[0075] The third step is to extract the angular stiffness k.sub.? corresponding to the equivalent Young's modulus E. This can also be done through finite element modeling. For the example of
gives the angular stiffness k.sub.? corresponding to the measured flexibility (C.sub.AB).sub.exp.
[0076] Based on the operating principles described above and with reference to
[0077] In one example, the step of determining an angular stiffness of the implant system 100 based on the motion data comprises transmitting the motion data to a user interface 216, and the user interface 216 is configured to determine the angular stiffness of the implant system based on the motion data. As such, the step of determining the angular stiffness of the implant system 100 based on the motion data may be performed by the controller 208 (e.g., firmware loaded in read only memory (ROM) and stored in the controller 208), or by the user interface 216 (e.g., software loaded in the user interface 216).
[0078] The controller 208 may take a variety of forms. The controller 208 can be any type of control unit including, but not limited to, a microprocessor, a microcontroller, a digital signal processor, or any combination thereof. The controller 208 can communicate with the end-user either via its USB port or its built-in Bluetooth antenna. Additionally, the controller 208 has the hardware capabilities to communicate with the motion sensor 206 (e.g., via Serial Peripheral Interface (SPI) as a non-limiting example). The main functions of the controller 208 are (a) to provide a DC voltage to drive the actuator 204, (b) to power the motion sensor 206 and to read the measured motion data, and (c) to transmit the motion data to the user interface 216 via a wired (e.g., USB) or a wireless link.
[0079] In one example, as shown in
[0080] In one example, the motion sensor 206 comprises an accelerometer (such as a MEMS accelerometer as a non-limiting example), and the motion data comprises acceleration data. In another example, the motion sensor 206 may comprise any sensor capable of measuring motion and/or vibration.
[0081] In one example, the implant system includes an implant 104 implanted in a support 102 (e.g., a bone) and an abutment 106 coupled to the implant 104. In one such example, at least a portion of the abutment 106 is exposed and not directly coupled to the bone 102. In one such example, the housing 202 includes a cutout, and the abutment 106 is configured to be positioned at least partially within the cutout. As such, in one example the housing 202 does not directly contact the implant 104 of the implant system 100. In one example, the abutment 106 is configured to be press fit into the cutout of the housing 202. In another example, a latch mechanism or a cap may be used to couple the abutment 106 to the housing 202. The implant system 100 may comprise one of a dental implant, an abutment, a dental crown, a dental restoration, a bone screw, a plate, a hip implant, or a knee implant.
[0082] In one example, the implant system 100 includes a longitudinal axis extending from a first surface to a second surface opposite the first surface, the implant system 100 includes a second axis that is perpendicular to the longitudinal axis, and the angular stiffness corresponds to a stiffness of a rotation of the implant system 100 with respect to the second axis.
[0083] In one example, the controller 208 and/or the user interface 216 is further configured to provide a binary indication of whether or not the implant system 100 is stable based on the determined angular stiffness of the implant system 100. In another example, the controller 208 and/or the user interface 216 is further configured to provide a notification of a degree of stability of the implant system 100 based on the determined angular stiffness of the implant system 100. In one particular example, the notification of a degree of stability of the implant system 100 comprises three categories: stable, unstable, and marginal. Other degrees of stability are possible as well.
[0084] In one example, the actuator 204 is configured to vibrate at a first frequency which is measured by the motion sensor 206 to define a first motion data, the actuator 204 is configured to vibrate at a second frequency which is measured by the motion sensor 206 to define a second motion data, and the controller 208 and/or the user interface 216 determines the angular stiffness of the implant system 100 based on both the first motion data and the second motion data.
[0085] In one example, the actuator 204 comprises a first actuator, and the device further comprises a second actuator coupled to the housing 202, where the second actuator is configured to vibrate the implant system 100 when actuated. In one such example, the first actuator is configured to vibrate at a first frequency which is measured by the motion sensor 206 to define a first motion data, the second actuator is configured to vibrate at a second frequency which is measured by the motion sensor 206 to define a second motion data, and the controller 208 and/or the user interface 216 determines the angular stiffness of the implant system 100 based on both the first motion data and the second motion data.
[0086] The actuator 204 may take a variety of forms. In one example, the actuator 204 comprises a buzzer motor. In one particular example, the buzzer motor has a diameter of ?8 mm and thickness of 2 mm. The buzzer motor speed is rated at 15,000?20% rpm for 3V DC. At a given speed ?, the harmonic force F.sub.0 is found via the manufacturer's specifications and calibration. In another example, the actuator 204 comprises a piezoelectric actuator. Other actuators are possible as well. In one example, the actuator 204 is driven sinusoidally such that the motion data comprises digitized sinusoidal signals.
[0087] In one example, as discussed above, the motion data comprises acceleration data. In one such example, determining the angular stiffness of the implant system 100 based on the acceleration data comprises: (i) applying a nonlinear regression algorithm to extract a frequency ? and an amplitude A.sub.0 of the motion data, (ii) determining an experimentally measured flexibility (C.sub.AB).sub.exp of the implant system using the equation
wherein F.sub.0 is an amplitude of an actuator force, and (iii) determining the angular stiffness (k.sub.?) using the interpolation
wherein (k.sub.?).sub.i and (k.sub.?).sub.i+1 are angular stiffness predicted from a mathematical model of the implant system under two assumed elastic properties, whereas (C.sub.AB).sub.i and (C.sub.AB).sub.i+1 are respective flexibility predicted by the mathematical model with the two elastic properties.
[0088]
[0089] The user interface 216 may take a variety of forms. In one example, the controller 208 is integrated with and an integral part of the user interface 216. In another example, the controller 208 is separate from, but in wired or wireless communication with, the user interface 216. The user interface 216 may comprise an external device, such as a mobile phone, a tablet, a laptop, or other personal computer as examples.
[0090] The device 200 described above is unique in multiple ways. First, the housing 202, actuator 204, and motion sensor 206 make up a sensing unit that is small and may be disposable. As such, and as shown in
[0091] To test the device 200 described above, three buzzer motors N1, N2, and N3 were used to measure the angular stiffness k.sub.? of the implant test model. Motor N1 was tested twice on Day 1 and Day 2. Motors N2 and N3 were tested once on Day 2. Each test lasted for 5 minutes. Accelerometer data were collected continuously but analyzed every 20 seconds to extract the angular stiffness k.sub.?.
[0092] The nonlinear regression is then applied to the digitized acceleration data from the accelerometer to extract buzzer motor speed w and acceleration amplitude A.sub.0, as shown in
[0093]
[0094] Although four different motor runs lead to similar angular stiffness k.sub.?, they should be benchmarked or calibrated against angular stiffness k.sub.? obtained from other measurement methods in order to validate the function and accuracy of the stability tester. Table 1 below shows the average k.sub.? of the four motor runs.
TABLE-US-00001 TABLE 1 Average k.sub.? of four motor runs Test Average Benchmark Motor Day k.sub.? (N .Math. m) k.sub.? (N .Math. m) Difference N1 Day 1 113.34 125.18 9.46% N1 Day 2 101.50 125.18 18.9% N2 Day 2 120.80 125.18 3.50% N3 Day 2 109.27 125.18 12.7%
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[0096] The second step is to obtain a frequency response function of the implant test model. This was done by sending the force f(t) and velocity v(t) to a spectrum analyzer.
[0097] The third step is model identification by matching the resonance frequency. A high-fidelity finite element model is created to simulate the implant test model, as shown in
[0098] The fourth step is to predict the angular stiffness k.sub.?. Similar to
[0099]
[0100] In addition, for the method 300 and other processes and methods disclosed herein, the block diagram shows functionality and operation of one possible implementation of present embodiments. In this regard, each block may represent a module, a segment, or a portion of program code, which includes one or more instructions executable by a processor or computing device for implementing specific logical functions or steps in the process. The program code may be stored on any type of computer readable medium, for example, such as a storage device including a disk or hard drive. The computer readable medium may include non-transitory computer readable medium, for example, such as computer-readable media that stores data for short periods of time like register memory, processor cache and Random Access Memory (RAM). The computer readable medium may also include non-transitory media, such as secondary or persistent long term storage, like read only memory (ROM), optical or magnetic disks, compact-disc read only memory (CD-ROM), for example. The computer readable media may also be any other volatile or non-volatile storage systems. The computer readable medium may be considered a computer readable storage medium, for example, or a tangible storage device.
[0101] Initially, at block 302, the method 300 includes positioning a device adjacent the implant system. The device may comprise the device 200 of any of the embodiments described above. In particular, the device 200 may include (i) a housing 202, (ii) an actuator 204 coupled to the housing 202, and (iii) a motion sensor 206 coupled to the housing 202. At block 304, the method 300 includes actuating the actuator 204 of the device 200 to vibrate the implant system. At block 306, the method 300 includes determining, via the motion sensor 206, motion data of the implant system. At block 308, the method 300 includes determining an angular stiffness of the implant system based on the motion data.
[0102] In one example, the step of determining the angular stiffness of the implant system comprises (i) receiving, via a controller of the device, the motion data of the implant system, (ii) transmitting, via the controller, the motion data to a user interface, and (iii) determining, via the user interface, the angular stiffness of the implant system based on the motion data.
[0103] In another example, the motion data comprises acceleration data, and the step of determining the angular stiffness of the implant system comprises (i) applying a nonlinear regression algorithm to extract a frequency ? and an amplitude A.sub.0 of the acceleration data, (ii) determining an experimentally measured flexibility (C.sub.AB).sub.exp of the implant system using the equation
wherein F.sub.0 is an amplitude of an actuator force, and (iii) determining the angular stiffness (k.sub.?) using the interpolation
wherein (k.sub.?).sub.i and (k.sub.?).sub.i+1 are angular stiffness predicted from a mathematical model of the implant system under two assumed elastic properties, whereas (C.sub.AB).sub.i and (C.sub.AB).sub.i+1 are respective flexibility predicted by the mathematical model with the two elastic properties.
[0104] It should be understood that arrangements described herein are for purposes of example only. As such, those skilled in the art will appreciate that other arrangements and other elements (e.g. machines, interfaces, functions, orders, and groupings of functions, etc.) can be used instead, and some elements may be omitted altogether according to the desired results. Further, many of the elements that are described are functional entities that may be implemented as discrete or distributed components or in conjunction with other components, in any suitable combination and location, or other structural elements described as independent structures may be combined.
[0105] While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope being indicated by the following claims, along with the full scope of equivalents to which such claims are entitled. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.
[0106] Since many modifications, variations, and changes in detail can be made to the described example, it is intended that all matters in the preceding description and shown in the accompanying figures be interpreted as illustrative and not in a limiting sense. Further, it is intended to be understood that the following clauses (and any combination of the clauses) further describe aspects of the present description.