ALERT PROCESSOR FOR A BONE FIXATION DEVICE

Abstract

An adjustable bone fixation device for moving a bone includes at least two strut units, at least one meter and a system controller. Each strut unit includes a motor to move a strut. The meter measures a signal generated by the motor during the movement of its strut. The signal is useful in determining a torque or a current of the motor. The system controller activates at least two of the motors and uses the determined torque or the determined current to identify if there is a clinical situation of the bone or a system issue and provides an alert accordingly.

Claims

1. An adjustable bone fixation device for moving a bone, the device comprising: at least two strut units, each strut unit of the at least two strut units comprising a motor to move a strut; at least one meter to measure a signal generated by the motor during a movement of the respective strut, said signal useful in determining a torque or a current of said motor; a system controller to activate at least two motors of the at least two strut units and to determine said torque or said current of the at least two motors; and an alert processor to identify if said determined torque or said determined current indicates a clinical situation of the bone or a system issue and to provide an alert accordingly.

2. The device of claim 1, wherein said motor is a brushed motor and said at least one meter is a current meter.

3. The device of claim 1, wherein said motor is a brushless motor, wherein said at least one meter is a voltmeter and a rotational speedometer.

4. The device of claim 1, wherein the alert processor identifies a problem when at least one parameter of the determined torque or the determined current is out of a predetermined range for the at least one parameter.

5. The device of claim 1, wherein the alert processor determines that a single strut unit of the at least two strut units has a problem if a motor of the single strut unit has an out-of-range value for a parameter of the determined torque or the determined current.

6. The device of claim 1, wherein the alert processor determines said clinical situation if a majority of said motors have an out-of-range value for a parameter of their respective determined torques or determined currents.

7. The device of claim 1, wherein the alert processor determines that a single strut unit of the at least two strut units has a problem if a motor of the single strut unit has a sudden jump in a value for a parameter of the determined torque or the determined current.

8. The device of claim 7, wherein if the alert processor classifies the problem as an end of travel problem, the alert processor instructs the system controller to compare a current axial location of the single strut unit with a predefined travel limit for the single strut unit.

9. The device of claim 8, wherein the alert processor determines if a strut swap was not done or was forgotten and provides an appropriate alert.

10. The device of claim 1, wherein the alert processor determines that a single strut unit has a problem if the motor of the single strut unit has a continuous elevation of a value for a parameter of the determined torque during a treatment period.

11. The device of claim 1, wherein the alert processor identifies the clinical situation if a majority of said motors have a continuous elevation of a value for a parameter of the determined torques or the determined currents during a treatment period.

12. The device of claim 1, wherein said alert processor is located remotely to said device.

13. The device of claim 12, wherein said system controller comprises communication circuitry to communicate to an external device which communicates with the alert processor.

14. The device of claim 13, wherein the external device is a smartphone of a patient or a caregiver.

15. A method for an adjustable bone fixation device for moving a bone, the device having at least two strut units, each strut unit of the at least two strut units comprising a motor to move a strut, the method comprising: activating at least two motors of the at least two strut units; measuring signals generated by said at least two activated motors, said signals useful in determining torques or currents of said at least two motors; and identifying if the determined torques or currents indicate a clinical situation of the bone or a system issue and alerting accordingly.

16. The method of claim 15, wherein said at least two activated motors are brushed motors and said signals are current signals.

17. The method of claim 15, wherein said at least two activated motors are brushless motors, and wherein said signals are voltage signals or rotational speed signals.

18. The method of claim 15, wherein identifying if the determined torques or currents indicate the clinical situation comprises reviewing said determined torque or said determined current to determine when at least one parameter of said determined torque or said determined current is out of a predetermined range for the at least one parameter.

19. The method of claim 15, wherein identifying comprises determining that a single strut unit of the at least two strut units has a problem if a motor of the single strut unit has an out-of-range value for a parameter of the determined torque.

20. The method of claim 15, wherein identifying if the determined torques or currents indicate the clinical situation comprises determining said clinical situation if a majority of said motors have an out-of-range value for a parameter of their determined torques or determined currents.

21. The method of claim 15, wherein identifying if the determined torques or currents indicate the clinical situation comprises determining that a single strut unit has a problem if a motor of the single strut unit has a sudden jump in a value for a parameter of the determined torque or the determined current.

22. The method of claim 21, wherein if the problem is classified as an end of travel problem, comparing a current axial location of the single strut unit with a predefined travel limit for the single strut unit.

23. The method of claim 22, wherein identifying if the determined torques or currents indicate the clinical situation comprises determining if a strut swap was not done or was forgotten and providing an appropriate alert.

24. The method of claim 15, wherein identifying if the determined torques or currents indicate the clinical situation comprises determining that a single strut unit has a problem if the motor of the single strut unit has a continuous elevation of a value for a parameter of the determined torque or the determined current during a treatment period.

25. The method of claim 15, wherein identifying if the determined torques or currents indicate the clinical situation comprises identifying the clinical situation if a majority of said motors have a continuous elevation of a value for a parameter of the determined torques or the determined currents during a treatment period.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0035] FIG. 1 is a schematic illustration of an exemplary external bone fixation device;

[0036] FIGS. 2A and 2B are schematic illustrations of an exemplary motorized external bone fixation device and its control unit, respectively;

[0037] FIG. 3 is a graphical illustration showing typical extension over time of each of 6 struts of the device of FIG. 1;

[0038] FIGS. 4A and 4B are schematic illustrations of two embodiments of an alert system for an automated, motorized bone fixation device, constructed and operative in accordance with a preferred embodiment of the present disclosure;

[0039] FIG. 5 is a flow chart illustration of the operation of the alert systems of FIGS. 4A and 4B;

[0040] FIG. 6 is a schematic illustration of an alert system for one or more automated, motorized bone fixation devices; and

[0041] FIG. 7A is a schematic illustration of a further embodiment of an alert system for an automated, motorized bone fixation device, constructed and operative in accordance with a further preferred embodiment of the present disclosure; and

[0042] FIG. 7B is a flow chart illustration of the operation of the alert system of FIG. 7A.

DETAILED DESCRIPTION

[0043] The present disclosure relates to adjustable bone fixation devices generally, to automatic adjustable bone fixation devices in particular and to methods for adjustable bone fixation devices. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present disclosure may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present disclosure. It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.

[0044] It can be appreciated that there are many ways that a motorized bone fixation device could fail during treatment (e.g., not move properly when the motors are activated). For example, it may fail due to clinical situations, which are typically that the bone consolidation is not as expected and/or that soft tissue movement consumes a high force. In another example, it may fail due to system issues, such as that something is in the way of one or more struts (e.g., maybe the strut has dirt in it, or is stuck on a sheet, a couch, a pantleg, etc.) or that one or more of its struts have reached an end of its travel (e.g., is fully extended).

[0045] It can be appreciated that one indicator of pending failure is the amount of axial force generated by the motor(s) which move the struts of a motorized adjustable fixation device. When the force is out of a predefined range, there is something which is keeping the strut from moving properly. The challenge is to identify problematic situations that might cause the treatment to stop (or slow down) and to understand the nature of the problem (e.g., clinical issue or system issue).

[0046] It can be appreciated that the axial force may be measured in a motorized adjustable fixation device by checking the current of the strut motor(s). In a brushed DC motor, for example, the current is correlated to motor torque, and the motor torque is correlated to the axial load generated when the strut is moving. The current may be measured on each motor separately or in a single location if the motors are not activated simultaneously.

[0047] Reference is now made to FIG. 3, which illustrates an exemplary treatment taking place between a treatment start date and a treatment end date. As shown by the graph, the exemplary start date is 4 Sep. 2022, and the exemplary end date is 9 October. FIG. 3 illustrates multiple graphs 20 showing typical extension (in millimeters) over time of each of 6 struts, each one marked with a different symbol. Note that the struts in this example operate multiple times each day, though typically not at night, and that each strut has a slightly different trajectory as defined by the surgeon. The surgeon typically defines a different treatment plan for each patient.

[0048] FIG. 3 also shows graphs 22 of the current, in mA, applied to each motor 110 as measured by current meters of the struts. The current starts and stops, according to the activation timing of the motors 110. When the motors 110 are active, the measured current generally fluctuates within a predefined level. For example, the predefined level is between 170 and 286 mA. An example of this predefined, or acceptable current, level can be seen on graphs 22 of FIG. 3 during the first 10 days of the treatment up to, for example, 18 Sep. 2022. However, FIG. 3 shows that sometime on, for example, 19 Sep. 2022, the sensed current for a number of the struts peaked above 400 mA. The problem was fixed and the sensed current went back down to its normal levels until, for example, 9 Oct. 2022 when the currents jumped again to high values.

[0049] Reference is now made to FIG. 4A, which illustrates an automated, the motorized bone fixation device 300 having an alert processor 126, constructed and operative in accordance with an embodiment of the present disclosure. Device 300 comprises at least two strut units 102 and a system controller 304.

[0050] Each strut unit 102 may comprise a strut 106 and a motor 110 (e.g., an electric motor). System controller 304 may control the operation of strut units 102 according to a treatment plan of a physician 103, by starting and stopping the relevant electric motor 110 associated with the relevant strut 106, thereby moving the relevant strut 106.

[0051] In the embodiment of FIG. 4A, each electric motor 110 may be connected to a current meter 112 which may measure the current of its motor 110. As discussed hereinabove with respect to FIG. 3, the current sensed by current meter 112 may indicate an issue with one or more electric motor 110 or that one or more of the struts 106 may not be operating properly.

[0052] In the embodiment of FIG. 4A, system controller 304 may comprise a current log 122, in which each current meter 112 may store the current values it has sensed, a current parameter determiner 120, an alert processor 126 and a communication unit 124. Current parameter determiner 120 may determine various parameters of the current, such as the average current (e.g., for a given period of time), the peak current, change in the average current etc., and alert processor 126 may generate alerts if any of these values, or a combination of these values, or a combination of these values with those of another sensor, are outside of a predefined range, such as the predefined range discussed above with reference to FIG. 3. Current parameter determiner 120 may also regularly report on the activations of strut units 102 to physician 103 and may transmit alerts as they occur.

[0053] For example, current parameter determiner 120 may measure an average of each motor's absolute current along the course of the treatment and may store this information in current log 122. Alert processor 126 may check if the average current is a predefined percentage above its normal, where the percentage may be predefined or customizable and may typically be from 20-30%, 30-75%, or more than 75%, if desired.

[0054] Other parameters which current parameter determiner 120 may determine include the relative current change along the treatment for each motor and any sudden peak current of a specific motor, where a peak current may be defined as desired, such as being 20% above a normal current for a very short time, such as 0.02-0.5 seconds, or as being any other percentage, such as more than 75% above the normal current.

[0055] It can be appreciated that a measurement system formed of current parameter determiner 120, alert processor 126 and current meters 112 may identify a problem in the making and may provide an early warning to the caregiver or physician before the fixation device stops treatment entirely. Alternatively, or in addition, the measurement system may provide an understanding of the nature of a problem for an efficient repair. This early warning may enable the caregiver or physician to better adjust the treatment plan for a specific patient or to check or provide guidance to the patient on system related issues.

[0056] Reference is now made to FIG. 4B, which illustrates an alternative alert system, labeled 300, for a bone fixation device which has only a single current meter, here labeled 112, to be shared among strut units, here labeled 102, where each strut unit comprises its motor 110. In this embodiment, system controller 304 may separately activate each motor 110 according to the treatment plan, so that current meter 112 measures only the motor current used to activate the currently active strut unit 102. System controller 304 may indicate to current log 122 which strut unit 102 is the currently active one, so that current log 122 may store the measured current per currently active strut unit 102.

[0057] Current parameter determiner 120, alert processor 126 and communication unit 124 may operate as described in the embodiment of FIG. 4A.

[0058] Reference is now made to FIG. 5, which illustrates, in flow chart format, the operation of alert processor 126 when reviewing the data in current log 122 to determine if there is a problem and if there is a problem, whether it is a clinical problem or a system problem.

[0059] Initially, in step 200, current log 122 may receive the values of the current from the active current meter 112 or 112. At some predefined time, whether once a new current data is received, once a second, once a minute once a day or on some other schedule, current parameter determiner 120 may determine the average current (step 202), the average motor current (step 204) and whether or not there was the peak current (step 206), for each strut unit 102/102. If all of these values are within range, then there is no failure to be handled, as checked by alert processor 126 in step 230.

[0060] As can be seen, if a motor of a single strut 106 has an out-of-range average current, as checked in step 202, or if a motor of a single strut 106 has an average current which changes along the treatment, as checked in step 204, or if a motor of a single strut 106 has a sudden jump in its current, as checked in step 206, current parameter determiner 120 may determine, in steps 220, 222 and 224, respectively, that there is probably a problem with its strut. A sudden jump in current may be defined as a change (e.g., an abrupt change) in current, as checked in step 206, over a predetermined period of time that is greater than a predetermined current amount. If step 224 is positive, alert processor 126 may check if the relevant strut 106 is at the end of its predetermined travel limits (step 226) in which case, strut unit 102/102 may need to be replaced. To do so, alert processor 126 may ask system controller 304 to compare the current axial location of the relevant strut 102/102 to its predefined travel limits or may instruct communication unit 124 to ask the caregiver to check the relevant strut 102/102. Alert processor 126 may also ask the caregiver to check if the relevant strut unit 102/102 or ring 14 is near the bed or an obstacle, as that might block movement of the fixation device of which strut units 102/102 form a part.

[0061] However, if the motors of all or most of the struts have the same issues, it is likely either a clinical issue (e.g., a clinical situation) or a system issue (e.g., system problem). FIG. 5 shows that if a motor of a single strut has an out-of-range average current, as checked by alert processor 126 in step 202, or if a motor of a single strut has an average current which changes along the treatment, as checked in step 204, alert processor 126 may determine, in steps 208 and 210, respectively, that there is probably a clinical issue that needs to be addressed.

[0062] If motors of multiple struts have a sudden jump in their current, as checked in step 206, alert processor 126 may determine, in step 212 that there is probably a system issue that needs to be addressed.

[0063] It will be appreciated that, via the review of the output of current meter(s) 112, device 300 or 300 may enable the physician, care giver or patient to identify problems with the activation of the fixation device, whether they be system problems or clinical problems, and to address them accordingly.

[0064] It will further be appreciated that the review of the output of current meter(s) 112 may enable device 300 or 300 to determine if a strut swap was not done (e.g., performed) or was forgotten and to provide an appropriate alert.

[0065] Reference is now made to FIG. 6, which illustrates an alert system 400 for one or more automated, motorized bone fixation devices 100. In this embodiment, an alert unit 123, comprising current log 122, current parameter determiner 120 and alert processor 126, may be located remotely, such as on a separate server connected to a wide area network (WAN) such as the Internet, and may receive current data from multiple bone fixation devices 100.

[0066] As discussed with respect to FIG. 2B, each bone fixation device 100 may comprise system controller 104 which may communicate, via communication circuitry 270, to an external device. In system 400 of FIG. 6, the external device may be a smartphone 402 of the patient or of his/her caregiver and may comprise a communication gateway 404 and a user interface 406.

[0067] Each communication gateway 404 may be wirelessly connected to communication circuitry 270 of its associated bone fixation device 100 and may be wirelessly connected to alert unit 123 via any standard internet connection. Each communication gateway 404 may be configured to receive the raw current data from its associated system controller 104 and to transmit the data, immediately or at periodic intervals, to current log 122 of alert unit 123. Current log 122 may associate the data with the relevant strut of the relevant device 100.

[0068] Current parameter determiner 122 and alert processor 126 may operate as described hereinabove. Alert processor 126 may provide feedback to physician or surgeon 103 as well as back to user interface 406 of smartphone 402, thereby providing feedback to the patient or caregiver as well.

[0069] Alert unit 123 may also receive historical data from other bone fixation devices 100 and may review such data to provide recommendations for treatments.

[0070] It will be appreciated that alert unit 123 may provide surgeons 103 with real-time or close to real-time data about how their patients are faring with their bone fixation devices 100, enabling the surgeons 103 to provide relatively quick responses when issues arise.

[0071] It will be appreciated that the embodiment of FIGS. 4A and 4B utilizes electrical current as an indicator for torque on motors 110 and utilizes torque or current as an indicator for a clinical or a system condition, since in brushed motors, there is a direct and linear correlation between the current and the torque.

[0072] It can be appreciated that other measurements may be used to indicate torque on a motor, depending on the type of motor used. This is shown in FIGS. 7A and 7B, to which reference is now made, which show a further automated motorized bone fixation device, here labeled 700, having brushless motors 710.

[0073] In a brushless DC motor, the relationship between the applied voltage (V) and the load torque determines the rotational speed, in accordance with the following relationship:

[00001]$\begin{array}{cc}\mathrm{mechanical}\mathrm{power}=f\left(V\right)=\mathrm{torque}*\mathrm{rotational}\mathrm{speed}& \left(1\right)\end{array}$

[0074] As a result, by measuring voltage and rotational speed, the torque or load on the brushless motors 710, such as produced by the growth or lack thereof of the leg, may be determined.

[0075] As in the embodiment of FIGS. 4A and 4B, device 700 comprises at least two strut units, here labeled 702, and a system controller, here labeled 704. Each strut unit 702 comprises a strut 106 and a brushless electric motor 710. Each brushless electric motor 710 may be connected to a voltmeter 712, which may measure the voltage applied by its motor 710, and to a rotational speedometer 713, such as a rotational encoder, which may measure the rotational speed of its motor 710.

[0076] System controller 704 may comprise a data log 722, in which each meter 712 and 713 may store the voltage and rotational speed values it has sensed, a torque parameter determiner 720, an alert processor 726 and a communication unit 124. Torque parameter determiner 720 may determine the torque currently being applied by each motor 710, such as by using equation 1, and may then determine various parameters of the torque, such as the average torque (for a given period of time), the peak torque, change in the average torque etc. Alert processor 726 may generate alerts if any of these values, or a combination of these values, or a combination of these values with those of another sensor, are outside of a predefined range. Torque parameter determiner 720 may also regularly report on the activations of strut units 102 to physician 103 and may transmit alerts as they occur.

[0077] FIG. 7B is similar to FIG. 5 but illustrates the operation of alert processor 726 when reviewing the data in data log 722. In FIG. 7B, the data being reviewed are the parameters of the determined torque rather than of the measured current and thus, steps 200, 202, 204, 206 and 230 have been relabeled as steps 730, 732, 734, 736 and 738.

[0078] It will be appreciated that, the embodiments herein described determine torque in some way (either by measuring current in the brushed motor case or by calculating it from the measured voltage and rotational speed in the brushless motor case) and utilize the results as indication of the clinical or system state.

[0079] Unless specifically stated otherwise, as apparent from the preceding discussions, it is appreciated that, throughout the specification, discussions utilizing terms such as processing, computing, calculating, determining, or the like, refer to the action and/or processes of a general purpose computer of any type, such as a hardware controller, mobile computing devices, smart appliances, or similar electronic computing devices that manipulate and/or transform data within the computing system's registers and/or memories into other data within the computing system's memories, registers or other such information storage, transmission or display devices.

[0080] Embodiments of the present disclosure may include apparatus for performing the operations herein. This apparatus may be specially constructed for the desired purposes, or it may comprise a computing device or system typically having at least one processor and at least one memory, selectively activated or reconfigured by a computer program stored in the computer. The resultant apparatus when instructed by software may turn the general-purpose computer into inventive elements as discussed herein. The instructions may define the inventive device in operation with the computer platform for which it is desired. Such a computer program may be stored in a computer readable storage medium, such as, but not limited to, any type of disk, including optical disks, magnetic-optical disks, read-only memories (ROMs), volatile and non-volatile memories, random access memories (RAMs), electrically programmable read-only memories (EPROMs), electrically erasable and programmable read only memories (EEPROMs), magnetic or optical cards, Flash memory, disk-on-key or any other type of media suitable for storing electronic instructions and capable of being coupled to a computer system bus. The computer readable storage medium may also be implemented in cloud storage.

[0081] Some general-purpose computers may comprise at least one communication element to enable communication with a data network and/or a mobile communications network.

[0082] The processes and displays presented herein are not inherently related to any particular computer or other apparatus. Various general-purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct a more specialized apparatus to perform the desired method. The desired structure for a variety of these systems will appear from the description below. In addition, embodiments of the present disclosure are not described with reference to any particular programming language. It will be appreciated if a variety of programming languages may be used to implement the teachings of the disclosure as described herein.

[0083] While certain features of the disclosure have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.