EXTERNAL ADJUSTMENT DEVICE FOR DISTRACTION SYSTEM
20220387083 · 2022-12-08
Inventors
- Timothy John Payne (Santa Ana, CA, US)
- Kevin Oberkramer (Placentia, CA, US)
- Scott Pool (Laguna Hills, CA, US)
- Arvin Chang (Yorba Linda, CA, US)
Cpc classification
A61B17/7074
HUMAN NECESSITIES
A61B2017/00411
HUMAN NECESSITIES
International classification
A61B17/70
HUMAN NECESSITIES
Abstract
An external adjustment device includes at least one permanent magnet configured for rotation about an axis with a first handle extending linearly at a first end of the device and a second handle at a second end of the device, the second handle extending in a direction substantially off axis to the first handle. The external adjustment device further includes a motor mounted inside the first handle and a first button located in the proximity to one of the first handle or the second handle, the first button configured to be operated by the thumb of a hand that grips the one of the find handle or second handle. The first button is configured to actuate the motor causing the at least one permanent magnet to rotate about the axis in a first direction.
Claims
1. A method of monitoring rotation of one or more magnets in an external adjustment device, the method comprising: positioning a first sensor at a first position in relation to a first magnet of the external adjustment device; rotating the first magnet of the external adjustment device about an axis thereof; using the first sensor, sensing a change in a first magnetic field as the first magnet rotates; outputting a time-variable voltage from the first sensor to a processor, the time-variable voltage from the first sensor corresponding to an increase or a decrease in the first magnetic field; and using the processor, analyzing the time-variable voltage output from the first sensor, wherein a time-variable strength of the first magnetic field corresponds to rotation of the first magnet.
2. The method of claim 1, further comprising: positioning a second sensor at a second position in relation to a second magnet of the external adjustment device; rotating the second magnet of the external adjustment device about an axis thereof; using the second sensor, sensing a change in a second magnetic field as the second magnet rotates; outputting a time-variable voltage from the second sensor to the processor, the time-variable voltage from the second sensor corresponding to an increase or a decrease in the second magnetic field; and using the processor, analyzing the time-variable voltage output from the second sensor, wherein a time-variable strength of the second magnetic field corresponds to rotation of the second magnet.
3. The method of claim 2, wherein the first sensor is positioned at nine o'clock relative to the axis of the first magnet, and the second sensor is positioned at three o'clock relative to the axis of the second magnet.
4. The method of claim 1, wherein the analyzing further comprises graphing the time-variable output from the first sensor, and wherein the output voltage from the first sensor varies sinusoidally over time when the first magnet is rotating, and wherein the output voltage from the first sensor does not vary sinusoidally over time when the first magnet is not rotating.
5. The method of claim 2, wherein the analyzing further comprises graphing the time-variable output from each of the first and the second sensors, and wherein the output voltage from each of the first and the second sensors varies sinusoidally over time when each of the first and the second magnets are rotating.
6. The method of claim 5, wherein the output voltage from the first or the second sensor does not vary sinusoidally over time when the corresponding one of the first or second magnet is not rotating.
7. The method of claim 5, wherein the output voltages from the first and the second sensors are in phase when the first and the second magnets are rotating synchronously.
8. The method of claim 5, wherein a phase shift between the first sinusoidal output and the second sinusoidal output indicates the first magnet and the second magnet are rotating asynchronously.
9. The method of claim 8, wherein the phase shift further indicates that the asynchronously rotating first and second magnets are rotating at approximately the same angular speed.
10. The method of claim 1, further comprising displaying the time-variable voltage output of the first sensor on a display of the external adjustment device.
11. The method of claim 10, further comprising displaying a notification on the display indicating an operating condition of the external adjustment device.
12. The method of claim 3, further comprising: positioning a third sensor at a third position in relation to the first magnet of the external adjustment device, and a fourth sensor at a fourth position in relation to the second magnet of the external adjustment device; using the third sensor, sensing the change in the first magnetic field as the first magnet rotates; using the fourth sensor, sensing the change in the second magnetic field as the second magnet rotates; outputting a time-variable voltage from each of the third sensor and the fourth sensor to the processor, the time-variable voltage from the third sensor and the fourth sensor corresponding to the increase or the decrease in the first magnetic field and the second magnetic field, respectively; and using the processor, analyzing the time-variable voltage output from the third sensor and the fourth sensor.
13. The method of claim 12, wherein the third sensor is positioned at twelve o'clock relative to the axis of the first magnet, and the fourth sensor is positioned at twelve o'clock relative to the axis of the second magnet.
14. The method of claim 12, wherein the analyzing further comprises graphing the time-variable output from each of the third and the fourth sensors, wherein the output voltage from each of the third and the fourth sensors varies sinusoidally over time when each of the first and the second magnets are rotating, and wherein the output voltage from the third or the fourth sensor does not vary sinusoidally over time when the corresponding one of the first or second magnet is not rotating.
15. The method of claim 14, wherein a phase shift between the third sinusoidal output and the fourth sinusoidal output indicates the first magnet and the second magnet are rotating synchronously.
16. The method of claim 12, further comprising: positioning a fifth sensor at a fifth position and a sixth sensor at a sixth position in relation to the first magnet of the external adjustment device; using the fifth and the sixth sensors, sensing the change in the first magnetic field as the first magnet rotates; outputting a time-variable voltage from the fifth and the sixth sensors to the processor; wherein the time-variable voltage outputs from the fifth and the sixth sensors correspond to the increase or the decrease in the first magnetic field; positioning a seventh sensor at a seventh position and an eighth sensor at an eighth position in relation to the second magnet of the external adjustment device; using the seventh and eighth sensors, sensing the change in the second magnetic field as the second magnet rotates; outputting a time-variable voltage from the seventh and the eighth sensors to the processor; wherein the time-variable voltage outputs from the seventh and the eighth sensors correspond to the increase or the decrease in the second magnetic field; and using the processor, analyzing the time-variable voltage outputs from the fifth, the sixth, the seventh, and the eighth sensors.
17. The method of claim 16, wherein the fifth sensor is positioned at ten o'clock relative to the axis of the first magnet, the sixth sensor is positioned at four o'clock relative to the axis of the first magnet, the seventh sensor is positioned at two o'clock relative to the axis of the second magnet, and the eighth sensor is positioned at eight o'clock relative to the axis of the second magnet.
18. The method of claim 8, further comprising, upon observing the phase shift, resynchronizing the first and the second magnets such that they rotate synchronously.
19. The method of claim 1, further comprising: positioning a radially striped ring on the first magnet; positioning an optical sensor in proximity to the radially striped ring and the first magnet; using the optical sensor, sensing a change in angular motion of the radially striped ring as the first magnet rotates about the axis; outputting a time-variable voltage from the optical sensor to the processor, the time-variable voltage from the optical sensor corresponding to the change in angular motion of the radially striped ring; and using the processor, analyzing the time-variable voltage output from the optical sensor, wherein the change in angular motion of the radially striped ring corresponds to rotation of the first magnet.
20. A method of monitoring rotation of one or more magnets in an external adjustment device, the method comprising: implanting a distraction device within a subject's body, the distraction device having an adjustable portion for adjusting a dimension of the distraction device, the adjustable portion comprising a rotatable magnet configured to actuate the adjusting; positioning the external adjustment device in proximity to the rotatable magnet to cause distraction of the distraction device, wherein the external adjustment device comprises a first sensor at a first position in relation to a first magnet of the external adjustment device; rotating the first magnet of the external adjustment device about an axis thereof; using the first sensor, sensing a change in a first magnetic field as the first magnet rotates; outputting a time-variable voltage from the first sensor to a processor, the time-variable voltage from the first sensor corresponding to an increase or a decrease in the first magnetic field; and using the processor, analyzing the time-variable voltage output from the first sensor, wherein a time-variable strength of the first magnetic field corresponds to rotation of the first magnet.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
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[0030] The first handle 702 contains the motor 705 that drives a first external magnet 706 and a second external magnet 708 as best seen in
[0031] Distraction turns the magnets 706, 708 one direction and retraction turns the magnets 706, 708 in the opposite direction. Magnets 706, 708 have stripes 809 that can be seen in window 811. This allows easy identification of whether the magnets 706, 708 are stationary or, turning, and in which direction they are turning. This allows quick trouble shooting by the operator of the device. The operator can determine the point on the patient where the magnet of the distraction device 1000 is implanted, and can then put the external adjustment device 700 in correct location with respect to the distraction device 1000, by marking the corresponding portion of the skin of the patient, and then viewing this spot through the alignment window 716 of the external adjustment device 700.
[0032] A control panel 812 includes several buttons 814, 816, 818, 820 and a display 715. The buttons 814, 816, 818, 820 are soft keys, and able to be programmed for an array of different functions. In one configuration, the buttons 814, 816, 818, 820 have corresponding legends which appear in the display. To set the length of distraction to be performed on the distraction device 1000, the target distraction length 830 is adjusted using an increase button 814 and a decrease button 816. The legend with a green plus sign graphic 822 corresponds to the increase button 814 and the legend with a red negative sign graphic 824 corresponds to the decrease button 816. It should be understood that mention herein to a specific color used for a particular feature should be viewed as illustrative. Other colors besides those specifically recited herein may be used in connection with the inventive concepts described herein. Each time the increase button 814 is depressed, it causes the target distraction length 830 to increase 0.1 mm. Each time the decrease button 816 is depressed it causes the target distraction length 830 to decrease 0.1 mm. Of course, other decrements besides 0.1 mm could also be used. When the desired target distraction length 830 is displayed, and the external adjustment device 700 is correctly placed on the patient, the operator then holds down the distraction button 722 and the External Distraction Device 700 operates, turning the magnets 706, 708, until the target distraction length 830 is achieved. Following this, the external adjustment device 700 stops. During the distraction process, the actual distraction length 832 is displayed, starting at 0.0 mm and increasing until the target distraction length 830 is achieved. As the actual distraction length 832 increases, a distraction progress graphic 834 is displayed. For example a light colored box 833 that fills with a dark color from the left to the right. In
[0033] The two handles 702, 704 can be held in several ways. For example the first handle 702 can be held with palm facing up while trying to find the location on the patient of the implanted magnet of the distraction device 1000. The fingers are wrapped around the handle 702 and the fingertips or mid-points of the four fingers press up slightly on the handle 702, balancing it somewhat. This allows a very sensitive feel that allows the magnetic field between the magnet in the distraction device 1000 and the magnets 706, 708 of the external adjustment device 700 to be more obvious. During the distraction of the patient, the first handle 702 may be held with the palm facing down, allowing the operator to push the device down firmly onto the patient, to minimize the distance between the magnets 706, 708 of the external adjustment device and the magnet 1010 of the distraction device 1000, thus maximizing the torque coupling. This is especially appropriate if the patient is large or somewhat obese. The second handle 704 may be held with the palm up or the palm down during the magnet sensing operation and the distraction operation, depending on the preference of the operator.
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[0038] Independently, Hall effect sensors 924, 926, 928, 930, 932, 934, 936, 938 may be used as non-optical encoders to track rotation of one or both of the external magnets 706, 708. While eight (8) such Hall effect sensors are illustrated in
[0039] If independent stepper motors are used, the resynchronization process may simply be one of reprogramming, but if the two external magnets 706, 708 are coupled together, by gearing or belt for example, then a mechanical rework may be required. An alternative to the Hall effect sensor configuration of
[0040] Returning to
[0041] In still another embodiment, additional information may be processed by processor 915 and may be displayed on display 715. For example, distractions using the external adjustment device 700 may be performed in a doctor's office by medical personnel, or by patients or members of patient's family in the home. In either case, it may be desirable to store information from each distraction session that can be accessed later. For example, the exact date and time of each distraction, and the amount of distraction attempted and the amount of distraction obtained. This information may be stored in the processor 915 or in one or more memory modules (not shown) associated with the processor 915. In addition, the physician may be able to input distraction length limits, for example the maximum amount that can be distracted at each session, the maximum amount per day, the maximum amount per week, etc. The physician may input these limits by using a secure entry using the keys or buttons of the device, that the patient will not be able to access.
[0042] Returning to
[0043] For example, the motor 705 would be commanded to rotate the magnets 706, 708 in a first direction when distracting an antegrade placed distraction device 1000, and in a second, opposite direction when distracting a retrograde placed distraction device 1000. The physician may, for example, be prompted by the display 715 to input using the control panel 812 whether the distraction device 1000 was placed antegrade or retrograde. The patient may then continue to use the same external adjustment device 700 to assure that the motor 705 turns the magnets 706, 708 in the proper directions for both distraction and retraction. Alternatively, the distraction device may incorporate an RFID chip 1022 which can be read and written to by an antenna 1024 on the external adjustment device 700. The position of the distraction device 1000 in the patient (antegrade or retrograde) is written to the RFID chip 1022, and can thus be read by the antenna 1024 of any external adjustment device 700, allowing the patient to get correct distractions or retractions, regardless of which external adjustment device 700 is used.
[0044] While embodiments have been shown and described, various modifications may be made without departing from the scope of the inventive concepts disclosed herein. The invention(s), therefore, should not be limited, except to the following claims, and their equivalents.