Patent Description:
People suffer bone fractures each year. In many instances, a person that suffers a bone fracture is required to use a bone alignment device, or external fixator, to align two or more bones or pieces of bone. The bone alignment device often has multiple struts that are to be adjusted regularly (e.g., daily) in accordance with a prescription. The prescription specifies strut length adjustments to be made over time to ensure successful bone alignment.

Typically, the person suffering the bone fracture or a health care professional (HCP) adjusts the struts of the bone alignment device. It is often difficult for a patient or HCP to make the adjustments to each strut properly. That is, individuals often adjust the incorrect strut or adjust the strut to an incorrect length. Adjustments to the struts that do not comply with the prescription can cause significant setbacks to the care of the patient.

Thus, it would be beneficial to provide an easy to use apparatus, system, and method that confirms that adjustments to a strut of a bone alignment device are made properly. Additionally, it would be beneficial to provide real-time feedback to an individual adjusting a strut that indicates whether the correct strut is being adjusted and if the adjusted length is correct, in compliance with a given prescription. Further, it would be beneficial to length is correct, in compliance with a given prescription. Further, it would be beneficial to provide the real-time adjustment feedback or resulting strut adjustments to a remote HCP, thereby allowing the remote HCP to more effectively monitor the progress of the patient. <CIT> describes a method for adjusting the orientation of a first external fixator support member relative to a second external fixator support member; it also describes a device configured to adjust the length of the struts of an external fixation apparatus, the device being configured to be selectively connected to each strut of the external fixation apparatus, identify which strut it is connected to, adjust the length of the strut as prescribed by a treatment protocol and measure the length of the strut. <CIT> describes a medical device comprising a medical strut.

The invention relates to a strut measurement and feedback device as defined in claim <NUM> and to an external bone alignment device as defined in claim <NUM>.

The present disclosure provides a strut measurement and feedback device. The strut measurement and feedback device can be attached to a strut of an external fixator. The strut measurement and feedback device can confirm that the strut measurement and feedback device is attached to a proper strut to be adjusted. The strut measurement and feedback device can determine if a length adjustment to the strut is correct. The strut measurement and feedback device can provide real-time feedback to an individual as the length of the strut is being adjusted to ensure the length adjustment complies with a prescription for the length of the strut. As a result, a patient can more effectively comply with the prescription as adjustments to the strut are made over time, thereby improving the likelihood of successful bone alignment.

The strut measurement and feedback device can include a coupling component, includes a strut measurement component, and can include a communications interface. The coupling component enables the strut measurement and feedback device to be selectively attached and detached from a strut of an external fixator. The strut measurement component can determine which particular strut, the strut measurement and feedback device is attached to. The strut measurement component can also determine an absolute or relative positioning or length of a strut to which the strut measurement and feedback device is attached. The communications interface can provide measurement data and identification data regarding the strut to a user device to provide real-time feedback regarding adjustments to the length of the strut to an individual making the adjustments.

According to the invention, the strut measurement component includes a camera for visualizing markings on the strut that can be used to determine the motion, position, or length of the strut.

In one embodiment, the strut measurement component can include a scanner for reading a barcode of the strut to identify the strut.

In one embodiment, the strut measurement component can include a radio-frequency identification (RFID) scanner for reading an RFID tag of the strut to identify the strut.

In one embodiment, the communications interface component can include a wireless communications interface for transmitting the measurement data and the identification data regarding the strut to the user device.

In one embodiment, the strut measurement and feedback device may include a device to adjust a length of the strut to which the strut measurement and feedback device is attached.

In one embodiment, the device for adjusting the length of the strut is configured to be removably attached to the strut measurement and feedback device.

Also disclosed herein is a method for providing real-time feedback to an individual adjusting a strut of an external fixator using the strut measurement and feedback device, the method including attaching the strut measurement and feedback device to the strut, determining the strut to which the strut measurement and feedback device is attached, detecting an adjustment made to the strut including an initial length of the strut prior to adjustment, an ending length of the strut after the adjustment, and/or a measure of the change in length of the strut resulting from the adjustment, providing measurement data relating to the adjustment to a user device, comparing the adjustment to the strut to a predetermined prescription for adjusting the strut, and indicating to an individual implementing the adjustment whether or not the proper strut was adjusted or whether or not the adjusted length of the strut is correct.

In one embodiment, an external bone alignment device as defined in claim <NUM> is disclosed. In use, the bone alignment device is arranged and configured to align two or more bones or pieces of bone. The bone alignment device comprising a first bone coupling device arranged and configured to engage a patient's first bone or piece of bone, a second bone coupling device arranged and configured to engage a patient's second bone or piece of bone, a plurality of struts coupled to the first and second bone coupling devices, each of the plurality of struts being arranged and configured to be lengthened and shortened so that adjustment of the strut moves the first bone coupling device relative to the second bone coupling device, and a strut measurement and feedback device arranged and configured to: (i) selectively attach to one of the plurality of struts and (ii) provide real-time information regarding an absolute or relative positioning or length of the strut to which the strut measurement and feedback device is attached. The strut measurement and feedback device comprises a strut measurement component for providing real-time information regarding an absolute or relative positioning or length of the strut to which the strut measurement and feedback device is attached, wherein the strut measurement component includes a camera arranged and configured to read visualizing markings positioned on the strut to which the strut measurement and feedback device is attached, the visualizing markings determining a length of the strut.

In one embodiment, the strut measurement and feedback device includes a communication interface arranged and configured to communicate with a remote device to provide real-time feedback to an individual as the length of the strut to which the device is attached is being adjusted to ensure the length adjustment complies with a prescription for the length of the strut.

In one embodiment, the strut measurement and feedback device is arranged and configured to identify the strut to which it is attached from the plurality of struts.

In one embodiment, the strut measurement and feedback device can determine if a length adjustment to the strut to which it is attached is correct.

In one embodiment, the strut measurement and feedback device includes a coupling component arranged and configured to enable the strut measurement and feedback device to be selectively attached and detached from one of the plurality of struts, and a communications interface arranged and configured to provide measurement data to a user device to provide real-time feedback regarding adjustments to the length of the strut to an individual making the adjustments.

In one embodiment, the strut measurement component is also arranged and configured to determine the strut, from the plurality of struts, to which the strut measurement and feedback device is attached.

In one embodiment, the communications interface is also arranged and configured to provide identification data regarding the strut to a user device to provide real-time feedback regarding adjustments to the length of the strut to which the strut measurement and feedback device is attached.

The strut measurement component includes a camera arranged and configured to read visualizing markings positioned on the strut to which the strut measurement and feedback device is attached, the visualizing markings determining a length of the strut.

In one embodiment, the strut measurement component includes a scanner for reading a barcode positioned on the strut to which the strut measurement and feedback device is attached, the barcode identifying the strut to which the strut measurement and feedback device is attached.

In one embodiment, the strut measurement component includes a radio-frequency identification (RFID) scanner for reading an RFID tag positioned on the strut to which the strut measurement and feedback device is attached, the RFID tag identifying the strut to which the strut measurement and feedback device is attached.

In one embodiment, the communications interface component includes a wireless communications interface for transmitting measurement data and identification data regarding the strut to which the strut measurement and feedback device is attached to the user device.

In one embodiment, the strut measurement and feedback device includes a device to adjust a length of the strut to which the strut measurement and feedback device is attached.

In one embodiment, the device to adjust the length of the strut is arranged and configured to be removably attached to the strut measurement and feedback device.

In one embodiment, the strut measurement and feedback device is arranged and configured to detect an adjustment made to the strut to which the strut measurement and feedback device is attached, the adjustment information including one of providing an initial length of the strut prior to adjustment and an ending length of the strut after the adjustment, and a measure of the change in length of the strut resulting from the adjustment.

In one embodiment, the external bone alignment device further comprises the user device arranged and configured to compare the adjustment to the strut to a predetermined prescription for adjusting the strut and indicating to an individual implementing the adjustment whether or not the proper strut was adjusted or whether or not the adjusted length of the strut is correct.

In one embodiment, a strut measurement and feedback device, as defined in claim <NUM>, to measure and provide feedback associated with an external bone alignment device is also disclosed. The device comprises a coupling component arranged and configured to selectively attach to one of a plurality of struts of the external bone alignment device, the external bone alignment device arranged and configured to align two or more bones or pieces of bone, the external bone alignment device comprising a first bone coupling device arranged and configured to engage a patient's first bone or piece of bone, a second bone coupling device arranged and configured to engage a patient's second bone or piece of bone, the plurality of struts coupled to the first and second bone coupling devices, each of the plurality of struts being arranged and configured to be lengthened and shortened so that adjustment of the strut moves the first bone coupling device relative to the second bone coupling device; and circuitry to provide real-time information regarding an absolute or relative positioning or length of the strut to which the strut measurement and feedback device is attached.

In one embodiment, the circuitry includes a communication interface arranged and configured to communicate with a remote device to provide real-time feedback to an individual as the length of the strut to which the device is attached is being adjusted to ensure the length adjustment complies with a prescription for the length of the strut.

In one embodiment, the circuitry is arranged and configured to identify the strut to which it is attached from the plurality of telescopic struts.

In one embodiment, the circuitry can determine if a length adjustment to the strut to which it is attached is correct.

The circuitry can include the coupling component arranged and configured to enable the strut measurement and feedback device to be selectively attached and detached from one of the plurality of struts, includes a strut measurement component for providing real-time information regarding an absolute or relative positioning or length of the strut to which the strut measurement and feedback device is attached, and can include a communications interface arranged and configured to provide measurement data to a user device to provide real-time feedback regarding adjustments to the length of the strut to an individual making the adjustments.

In one embodiment, the strut measurement component is also arranged and configured to determine the strut, from the plurality of struts, to which the circuitry is attached.

In one embodiment, the communications interface is also arranged and configured to provide identification data regarding the strut to a user device to provide real-time feedback regarding adjustments to the length of the strut to which the circuitry is attached.

According to the invention, the strut measurement component includes a camera arranged and configured to read visualizing markings positioned on the strut to which the circuitry is attached, the visualizing markings determining a length of the strut.

In one embodiment, the strut measurement component includes a scanner for reading a barcode positioned on the strut to which the circuitry is attached, the barcode identifying the strut to which the circuitry is attached.

In one embodiment, the strut measurement component includes a radio-frequency identification (RFID) scanner for reading an RFID tag positioned on the strut to which the circuitry is attached, the RFID tag identifying the strut to which the circuitry is attached.

In one embodiment, the communications interface component includes a wireless communications interface for transmitting measurement data and identification data regarding the strut to which the circuitry is attached to the user device.

In one embodiment, the circuitry includes a device to adjust a length of the strut to which the circuitry is attached.

In one embodiment, the device to adjust the length of the strut is arranged and configured to be removably attached to the circuitry.

In one embodiment, the circuitry is arranged and configured to detect an adjustment made to the strut to which the circuitry is attached, the adjustment information including one of providing an initial length of the strut prior to adjustment and an ending length of the strut after the adjustment, and a measure of the change in length of the strut resulting from the adjustment.

Further features and advantages of at least some of the embodiments of the present invention, as well as the structure and operation of various embodiments of the present invention, are described in detail below with reference to the accompanying drawings.

By way of example, a specific embodiment of the disclosed device will now be described, with reference to the accompanying drawings, in which:.

The drawings are merely representations, not intended to portray specific parameters of the disclosure. The drawings are intended to depict various embodiments of the disclosure, and therefore are not be considered as limiting in scope. In the drawings, like numbering represents like elements.

Devices, systems, and methods for providing real-time feedback on the length of a strut of an external fixator are provided. The real-time feedback can ensure that the length of each strut is adjusted correctly in compliance with a predetermined prescription for facilitating fracture alignment. The real-time feedback can be provided by a device that can attach to a strut and wirelessly transmit linear distance measurements to, for example, a user device. Indications as to whether the adjusted length of the strut are correct can be presented to an individual in real-time while the individual is adjusting the strut length. Once the correct strut length is reached, the device can be detached and attached to a next strut of the external fixator. In this manner, each strut of the external fixator can be adjusted to the proper length, in compliance with the predetermined prescription. Further, the device can identify each strut which is being adjusted. Additionally, measurement data for each strut can be stored and provided to a remote health care provider (HCP) to provide the HCP with more detailed information regarding progress of the patient and conformance to the predetermined prescription.

<FIG> illustrates an embodiment of a bone alignment device <NUM>. The bone alignment device <NUM> can be an external fixator. The bone alignment device <NUM> can include a first bone coupling mechanism, member, device, etc., a second bone coupling mechanism, member, device, etc., and a plurality of interconnected telescopic struts. For example, as shown in <FIG>, in one embodiment, the bone alignment device <NUM> can form a hexapod having a circular, metal frame with a first ring <NUM> and a second ring <NUM> connected by six telescopic struts <NUM> (labeled as struts <NUM>-<NUM> through <NUM>-<NUM> in <FIG>). Each strut <NUM> can be independently lengthened or shortened relative to the rest of the frame, thereby allowing for six different axes of movement.

In one embodiment, each strut <NUM> may include an outer body component and an inner rod component (e.g., a threaded rod). To lengthen or shorten one of struts <NUM>, the outer body component and the inner rod component can be moved or translated relative to one another. Thus arranged, each strut may be in the form of a telescopic device. Often a strut pin coupled to the inner rod component can be visualized within a slot or opening formed in the outer body component to determine the relative movement of the inner rod component relative to the outer body component. For example, as the inner rod component is translated relative to the outer body component, the strut pin moves in unison with the inner rod component within the slot of the outer body component.

As will be described herein, the features according to the present disclosure may be used with any suitable bone alignment device now known or hereafter developed. In this regard, the present disclosure should not be limited to the details of the bone alignment device and/or struts disclosed and illustrated herein unless specifically claimed and that any suitable bone alignment device can be used in connection with the principles of the present disclosure.

The bone alignment device <NUM> can be used to treat a variety of skeletal fractures of a patient. Typically, the bone alignment device <NUM> is positioned around the patient and is used to align two or more bones or pieces of bone. To do so, a length of each strut <NUM> can be incrementally adjusted (e.g., shortened or lengthened) in accordance with a prescription that specifies adjustments to be made to each strut <NUM> over time to ensure successful bone alignment. In many instances, the length of each strut <NUM> should be adjusted daily to comply with the provided prescription. As such, in use, a prescription may, for example, designate a specific amount of adjustment that needs to be made to each strut on, for example, a daily basis. In use, each strut may be adjusted daily by a varying amount.

The adjustments to the struts <NUM> are usually made by either the patient or a caregiver. To make an adjustment, an individual can refer to a graduated scale that is laser etched onto each strut <NUM>. The scale, however, can be difficult for the individual making the adjustments to observe when the bone alignment device <NUM> is positioned on the patient. The individual making the adjustment may also rely on a tactile "click" that can be felt by the patient when the length of the strut <NUM> is adjusted by a fixed amount (e.g., <NUM>). The tactile click, however, does not indicate the direction in which the strut <NUM> was adjusted. In addition, individuals may often adjust the incorrect strut (e.g., on a daily basis, each strut may need to be adjusted a different amount, the individual may inadvertently adjust the wrong strut, or adjust the correct strut by an incorrect amount). Furthermore, an individual may inadvertently rotate one or more struts in the wrong direction thereby, for example, shortening a strut instead of lengthening the strut. Thus, despite implementing safeguards such as, for example, the inclusion of the scale and the tactile click, it may be difficult for individuals to confirm that the proper length of the strut <NUM> was reached as specified by the prescription when an adjustment to the strut <NUM> is made. As a result, it is common for individuals to not comply with the prescription when an adjustment is made.

A patient generally has follow-up clinical visits, for example, a patient may have a clinical visit every two weeks, so that the patient's clinician can evaluate the patient's progress and modify the bone alignment device <NUM> or related prescription as necessary. Incorrect adjustments to the struts <NUM> that can occur between clinical visits can result in significant deviations in the correction path of the bone fragments compared to what was prescribed, thereby causing significant setbacks in the treatment of the patient.

<FIG> illustrates an embodiment of a compliance monitoring system <NUM> that can be used to monitor strut compliance in connection with an external fixation system. The compliance monitoring system <NUM> can include an external fixator <NUM>, a strut measurement and feedback device <NUM>, and a user device <NUM>. In various embodiments, the external fixator <NUM> can be the bone alignment device <NUM> depicted in <FIG>. Alternatively, the external fixator <NUM> can be any other bone alignment device now known or hereafter developed.

In use, the strut measurement and feedback device <NUM> can be selectively coupled to each strut of the external fixator <NUM>. In one embodiment, the strut measurement and feedback device <NUM> can be coupled to each strut one at a time. In use, in one embodiment, the strut measurement and feedback device <NUM> can determine which strut the strut measurement and feedback device <NUM> is coupled to and can provide real-time feedback as to the position of each strut (e.g., can determine absolute position of each strut, which can then be used to determine the change in length which the strut undergoes by, for example, comparing the start position to the finish position). The real-time feedback can be provided to the user device <NUM> to enable a patient, a caregiver, a health care professional (HCP), or whoever is making the adjustments to verify that adjustments to the struts of the external fixator <NUM> are being properly made in compliance with a predetermined prescription.

That is, as will be described in greater detail herein, in use, the strut measurement and feedback device <NUM> can take on any of a number of different forms. The strut measurement and feedback device <NUM> can perform one or more of the following features, among others: collect data, process data, transmit data, receive data and/or provide feedback. For example, in some embodiments, the strut measurement and feedback device <NUM> can perform all of these features. Alternatively, in some embodiments, the strut measurement and feedback device <NUM> can collect data and transmit data to, for example, the user device <NUM>, which can process the data and/or provide feedback. Thus arranged, in use, the strut measurement and feedback device <NUM>, either alone or in combination with, the user device <NUM>, can determine/detect what specific strut the strut measurement and feedback device <NUM> is coupled to (e.g., strut <NUM>-<NUM> or <NUM>-<NUM>, <NUM>-<NUM>, etc.), determine if it is attached properly to the strut (e.g., indicate if the strut measurement and feedback device <NUM> is correctly or incorrectly attached to the strut), detect the initial position of the strut (e.g., initial length of strut), detect the adjusted position of the strut (e.g., adjusted length of the strut), and/or determine change in length of the strut, transmit data to, for example, the user device <NUM>, receive data (e.g., the prescription) from, for example, the user device <NUM>, store a patient's prescription for adjusting the position of the various struts, compare data including the adjusted length or the adjusted position of the strut to the prescription, check for compliance with the prescription, provide feedback or indication of compliance and/or non-compliance, etc..

In use, after coupling the strut measurement and feedback device <NUM> to a strut in the external fixator <NUM>, the strut measurement and feedback device <NUM> determines (e.g., measures) changes to the length of the strut of the external fixator <NUM>. That is, in use, the strut measurement and feedback device <NUM> can measure and/or monitor a position of a strut to which it is coupled (e.g., can measure or monitor an absolute or relative position of the inner rod component relative to the outer rod component). In addition, the strut measurement and feedback device <NUM>, either alone or in combination with the user device <NUM>, can indicate if the adjustment is being made to the correct strut, can indicate if the direction of adjustment is proper, and/or can indicate if the adjusted length complies with the predetermined prescription.

The strut measurement and feedback device <NUM> can communicate directly or indirectly with the user device <NUM>. The user device <NUM> may be any suitable user device now known or hereafter developed including, for example, an electronic device and/or a computing device such as, for example, a smartphone, a tablet, a laptop, a notebook, a netbook, a personal computer (PC), etc. In various embodiments, the strut measurement and feedback device <NUM> and the user device <NUM> can communicate over any known wireless communication standard or protocol. Example wireless connections and/or protocols may include, for example, Wi-Fi (e.g., any IEEE <NUM> a/b/g/n network), Bluetooth, Bluetooth Low Energy (BLE), Near-Field Communication (NFC), any cellular communication standard, any infrared communication protocol, etc..

The communication connectivity between the strut measurement and feedback device <NUM> and the user device <NUM> enables data or information such as, for example, measurement data, strut identification data, compliance data, etc. determined by the strut measurement and feedback device <NUM> to be provided to the user device <NUM> for review by the patient or HCP. Accordingly, as adjustments are made to each strut of the external fixator <NUM>, the user device <NUM> can present real-time measurement and/or compliance data determined by the strut measurement and feedback device <NUM>. As a result, the patient or HCP can more easily determine if adjustments are being properly made (e.g., direction and amount of displacement) and if adjustments are being made to the proper strut.

As further shown in <FIG>, the user device <NUM> can communicate directly or indirectly with one or more remote computing devices, remote computer networks, and/or remote cloud networks or platforms <NUM> (collectively referred to as "remote devices <NUM>" without intent to be limiting). The real-time data including, for example, the measurement data, monitoring data, etc. provided by the strut measurement and feedback device <NUM> to the user device <NUM> can be relayed to the remote devices <NUM>. This enables a remote HCP to monitor in real-time the patient's compliance with the predetermined prescription. In an embodiment, real-time measurement and/or compliance data determined by the strut measurement and feedback device <NUM> can be provided to one or more remote devices <NUM> after an adjustment to a strut of the external fixator <NUM> has been made or after adjustments to all struts have been made. Alternatively, real-time measurement and/or compliance data determined by the strut measurement and feedback device <NUM> can be provided to one or more remote devices <NUM> in real-time (e.g., as adjustments to any strut are being made), thereby allowing a remote HCP to directly interact with the individual making the adjustments through communications with the user device <NUM>.

In various embodiments, the user device <NUM> can include software or an application (e.g., an "app") that receives real-time data (e.g., measurement data, compliance data, etc.) determined by the strut measurement and feedback device <NUM>. The app on the user device <NUM> can provide feedback to the individual adjusting the external fixator <NUM> as adjustments are made. The feedback can be any feedback include, for example, visual, tactile, and/or audible feedback. The feedback provided through the user device <NUM> based on real-time measurement and/or compliance data determined by the strut measurement and feedback device <NUM> can increase a likelihood that adjustments to the external fixator are made properly and/or comply with a prescription. In various embodiments, the user device <NUM>, including the capabilities, features, and/or functionality of the user device <NUM>, as well as the capabilities, features, and/or functionality of any software or app provided on the user device <NUM>, can be as described in <CIT>.

The prescription for movement of the struts of the external fixator <NUM> can be stored remotely (e.g., on one or more remote devices <NUM>) and/or can be stored on the user device <NUM>. The real-time measurement and/or compliance data determined by the strut measurement and feedback device <NUM> can be compared to the stored prescription either locally or remotely to provide feedback to the individual adjusting the struts of the external fixator <NUM>. Accordingly, the feedback provided to the individual adjusting the external fixator <NUM> can originate remotely (e.g., by one or more remote device <NUM>) and can be transmitted to the user device <NUM> or can originate locally (e.g., by the app running on the user device <NUM>).

The communication connectivity between the patient, the individual adjusting the external fixator <NUM>, and a remote HCP by the compliance monitoring system <NUM> enables additional data or information to be shared. In various embodiments, visual, textual, and/or voice data or other information can be shared between the user device <NUM> and a remote computing device <NUM>. In this way, the patient, HCP, and/or other individual adjusting the external fixator <NUM> can communicate with a remote HCP or other individual as adjustments are being made or at any other time. In various embodiments, the patient coupled to the external fixator <NUM> can transmit information related to pain or any other discomforts to the remote HCP. In various embodiments, the remote HCP can modify the prescription for the use of the external fixator <NUM> and can transmit it to the user device <NUM> for storage and/or use.

The strut measurement and feedback device <NUM> may be any suitable device now known or hereafter developed that can be attached and detached from a strut of the external fixator <NUM>, that can determine an absolute and/or relative positioning the strut (e.g., determine adjusted length of a strut by, for example, comparing a start position versus a finish position), and can provide data or other information regarding the adjusted length, and/or absolute and/or relative positioning of the strut as adjustments to the strut are being made. In this way, the patient and/or HCP adjusting the external fixator <NUM> can properly adjust the struts, thereby improving the care provided to the patient and ensuring compliance with a predetermined prescription for adjusting the external fixator <NUM>. Further, a remote HCP can monitor treatment progress remotely based on connectivity between the user device <NUM> and the one or more remote devices <NUM>. In addition, as will be described herein, the strut measurement component or module <NUM> can also determine which particular strut the strut measurement and feedback device <NUM> is attached.

Various embodiments, features, and/or capabilities of the strut measurement and feedback device <NUM> are described below. In various embodiments, as described herein, the strut measurement and feedback device <NUM> can include components to visualize markings (e.g., a scale) provided on a strut of the external fixator <NUM>. By visualizing the markings provided on the strut, the strut measurement and feedback device <NUM> can determine an absolute position of the strut as adjustments to the strut are made.

In various other embodiments, as described herein, the strut measurement and feedback device <NUM> can include components to measure a distance from a fixed point on a strut body to either the bottom of a rod positioned within the strut or to a pin positioned within a slot of the strut. Because each strut of the external fixator <NUM> can have different lengths, the measured distance can be the same for two struts having different overall lengths. Accordingly, the strut measurement and feedback device <NUM> can further determine the strut on which it is attached. By knowing the strut to which it is attached, the strut measurement and feedback device <NUM> and/or the user device <NUM> can determine an accurate measure of an adjusted length for the strut based on the aforementioned measured distance. Information regarding the length of each strut of the external fixator <NUM> can be stored and/or accessible to the strut measurement and feedback device <NUM> and/or the user device <NUM> for making an accurate determination of the length of a strut (e.g., a true or absolute strut length).

<FIG> illustrates an embodiment of the strut measurement and feedback device <NUM>. Specifically, <FIG> provides a block diagram of circuitry <NUM> to interconnect functional components of the strut measurement and feedback device <NUM>. As shown, the strut measurement and feedback device <NUM> may include a coupling component or module <NUM> for selectively coupling and detaching the strut measurement and feedback device <NUM> to and from the strut. The coupling component <NUM> can provide one or more mechanisms for coupling and decoupling the strut measurement and feedback device <NUM> to a strut of the external fixator <NUM>. The coupling component <NUM> can include one or more mechanical components, electrical components, electromechanical components, or any combination thereof.

The strut measurement and feedback device <NUM> may include a strut measurement component or module <NUM>. The strut measurement component <NUM> enables the strut measurement and feedback device <NUM> to determine an absolute and/or a relative positioning of a strut to which the strut measurement and feedback device <NUM> is coupled. The strut measurement component or module <NUM> can also determine to which particular strut the strut measurement and feedback device <NUM> is attached. The strut measurement component can include one or more mechanical components, electrical components, electromechanical components, or any combination thereof.

The strut measurement and feedback device <NUM> may include a wireless communications interface <NUM>. The wireless communications interface <NUM> may provide interfaces for communicating with any local or remote device or network through any wireless communication technology. The wireless communications interface <NUM> enables the strut measurement and feedback device <NUM> to wirelessly transmit and receive data or information with the user device <NUM> and/or one or more remote computing devices <NUM> either directly or indirectly.

The strut measurement and feedback device <NUM> may include one or more output devices or components <NUM>. The output devices <NUM> can provide visual, audible, and/or tactile feedback to the user of the strut measurement and feedback device <NUM>. In various embodiments, the output device <NUM> can include one or more speakers, one or more light emitting diodes (LEDs), and/or a display (e.g., a touchscreen). The output devices <NUM> can indicate to the user of the strut measurement and feedback device <NUM> whether or not the strut measurement and feedback device <NUM> is being used properly (e.g., if the strut measurement and feedback device <NUM> is attached properly or improperly) and/or can indicate whether a strut measurement is in progress, is complete, and/or was done incorrectly or erroneously.

The strut measurement and feedback device <NUM> may include a power source <NUM>. The power source <NUM> may include electrical power connections and/or a battery. The power source <NUM> may provide power to any of the constituent functional components of the strut measurement and feedback device <NUM> depicted in <FIG>. In various embodiments the power source can be a rechargeable battery or, alternatively, a replaceable battery.

The strut measurement and feedback device <NUM> may further include a processor circuit <NUM> and an associated memory component <NUM>. The memory component <NUM> may store one or more programs for execution by the processor circuit <NUM> to implement one or more functions or features of the strut measurement and feedback device <NUM> as described herein. The processor circuit <NUM> may be implemented using any processor or logic device. The memory component <NUM> can be implemented using any machine-readable or computer-readable media capable of storing data, including both volatile and non-volatile memory.

The processor circuit <NUM> may implement the functionalities of any of the components depicted in <FIG> or may control or adjust operation of any of the depicted components. Each component depicted in <FIG> may be coupled to the processor circuit <NUM> as well as any other depicted component. For instance, the processor circuit <NUM> may, in some embodiments, determine a strut identifier (ID) from a strut and store the strut ID in memory <NUM>, compare the strut ID with a strut ID associated with an adjustment to determine if the strut measurement and feedback device <NUM> is coupled with the correct strut to perform the adjustment. In further embodiments, the processor circuit <NUM> may, in some embodiments, compare a strut adjustment performed on the external fixator <NUM> (also referred to as a bone alignment device or external bone alignment device) with a prescribed adjustment for the same strut ID in the memory <NUM> to determine if the strut adjustment matches the prescribed adjustment. In several embodiments, the processor circuit <NUM> may communicate with the wireless communications interface <NUM> and/or the output device(s) <NUM> to provide real-time feedback to a remote individual and/or an individual performing the adjustments to the struts of the external fixator <NUM>. The depicted components may be implemented in hardware or software as appropriate, or any combination thereof.

Various embodiments of the strut measurement and feedback device <NUM> are described herein. The various embodiments may vary by shape, size, and/or form factor. The various embodiments may vary by implementation of the constituent components described in relation to <FIG>. Features and/or functionalities of any described embodiment can be combined or used in combination with features and/or functionalities of any other embodiment described herein as will be appreciated by one skilled in the relevant arts.

<FIG> illustrates a first embodiment of a strut measurement and feedback device <NUM>. The strut measurement and feedback device <NUM> may represent the strut measurement and feedback device <NUM> as depicted in <FIG> and <FIG>. As shown in <FIG>, the strut measurement and feedback device <NUM> is coupled to a strut <NUM>. The strut <NUM> can be a strut of the external fixator <NUM> as depicted in <FIG>.

The strut measurement and feedback device <NUM> may include a high-resolution camera <NUM>. The camera <NUM> may be used to visualize laser markings (not shown in <FIG> for simplicity) on the outside of the strut <NUM>. The camera <NUM> may also be used to visualize movement of a strut pin (not shown in <FIG> for simplicity) positioned within a slot <NUM> of the strut <NUM>. Multiple images of the strut pin can be captured and analyzed to calculate the motion of the strut pin within the slot <NUM>. In various embodiments, the motion of the strut pin can be analyzed using image processing functionality residing on the strut measurement and feedback device <NUM> (e.g., image processing software stored on the strut measurement and feedback device <NUM>). In various embodiments, the motion of the strut pin can be analyzed using image processing functionality residing on the user device <NUM> (e.g., image processing software stored on the user device <NUM>).

Image processing capabilities residing on the user device <NUM> and/or the strut measurement and feedback device <NUM> may be used to "read" a strut length from laser markings on the body of the strut <NUM> using Optical Character Recognition (OCR) or similar image processing capability. In this way, a measurement of the length of the strut <NUM> may be "absolute," enabling the user device <NUM> and/or the strut measurement and feedback device <NUM> to determine the starting length and the ending length of any strut to which the strut measurement and feedback device <NUM> is attached by analyzing multiple images of the laser markings as the strut is moved.

In various embodiments, the strut <NUM> can include a unique marking pattern that could be recognized by the camera <NUM>. The marking pattern can be any type of pattern including, for example, a dot matrix pattern. The marking pattern may allow for enhanced resolution and accuracy, as the markings for the camera <NUM> would not have to be human readable.

In various embodiments, the strut measurement and feedback device <NUM> can have a shape and/or a form factor that allows the strut measurement and feedback device <NUM> to snap over an outer diameter of the strut <NUM> while allowing the strut measurement and feedback device <NUM> to slide along the strut <NUM>. As shown in <FIG>, the strut measurement and feedback device <NUM> can resemble a C-Clip housing but is not so limited.

In a first additional embodiment, a user can slide the strut measurement and feedback device <NUM> along the strut <NUM> in any direction until the camera <NUM> is positioned over the strut pin in the slot <NUM>. When the camera <NUM> is positioned over the strut pin, any combination of visual and/or audible signals can be provided by the strut measurement and feedback device <NUM> to indicate to the user that the strut measurement and feedback device <NUM> is properly positioned.

In a second additional embodiment, the strut pin can be made to protrude out of the slot <NUM>. The strut measurement and feedback device <NUM> can then be moved by the user along the strut <NUM> until the strut measurement and feedback device <NUM> contacts the protruding strut pin.

In a third additional embodiment, the strut measurement and feedback device <NUM> can be coupled or connected to the strut pin such that the strut measurement and feedback device <NUM> translates along the strut <NUM> as the length of the strut <NUM> is changed. In each of the aforementioned embodiments, the strut measurement and feedback device <NUM> can be properly positioned and then left in place while adjustments to the length of the strut <NUM> are made. An accurate measurement of the absolute length of the strut <NUM> can then be made as the strut pin movement reflects the movement and therefore length of the strut <NUM>.

In various embodiments, the strut measurement and feedback device <NUM> can provide a measurement of an absolute length of the strut <NUM> when not coupled to the strut pin. Under such scenarios, the camera <NUM> may be provided with a minimum field of view sufficiently large to visualize the strut pin and identifiable laser marking located on the struts. In various embodiments, when the camera <NUM> includes a wide-angle lens, then the camera <NUM> may be able to visualize an entire length of the slot <NUM>. In various embodiments, when the camera <NUM> includes a wide-angle lens, then the strut measurement and feedback device <NUM> may be coupled to the strut <NUM> at a fixed location. For example, the strut measurement and feedback device <NUM> could be attached to a midpoint of the strut <NUM> and may not be movable along the length of the strut <NUM>. Alternatively, the strut measurement and feedback device <NUM> could be attached adjacent to one end of the strut <NUM>.

As described herein, as the strut measurement and feedback device <NUM> collects data related to the length of the strut <NUM> as adjustments are made to the strut <NUM>, the strut measurement and feedback device <NUM> can provide the collected measurement data to the user device <NUM> in real-time. The measurement data relating to the strut <NUM> can then be provided to user of the user device <NUM> in a user-facing app to allow the user to view the real-time length of the strut <NUM> length as adjustments are made. In various embodiments, the app can notify the user when the length of the strut <NUM> matches a prescribed strut length for the strut <NUM>. In various embodiments, the app can also provide feedback to indicate when an adjustment has overshot the prescribed length for the strut <NUM> and/or when an adjustment has been made in an improper direction.

The app can provide indications through one or more output devices of the user device <NUM>. As an example, the app can provide feedback through any combination of visual, audible, or haptic feedback through the user device <NUM>. Additionally, real-time data regarding the length of the strut <NUM> can be provided to a remote HCP through the one or more remote devices <NUM>. This allows a remote HCP of a patient the ability to assess patient compliance (e.g., in relation to the predetermined prescription) by monitoring the arrangement and position of the external fixator <NUM>.

In various embodiments, the strut measurement and feedback device <NUM> can automatically identify each strut of the external fixator <NUM>. In one embodiment, each strut of the external fixator <NUM> can include a color-coded identification (ID) band that the strut measurement and feedback device <NUM> can identify as a unique strut ID based on color recognition (e.g., using a color detection sensor). In a second embodiment, an ID band on each strut of the external fixator <NUM> can include an NFC device, such as a radio-frequency identification (RFID) tag, to identify a unique strut ID for each strut. The strut measurement and feedback device <NUM> can include an RFID tag reader to detect the unique RFID tag (strut ID) for a particular strut. In a third embodiment, each strut of the external fixator <NUM> can include a Quick Response (QR) code, barcode, or other similar scannable marking that can identify a unique strut ID for each strut. The strut measurement and feedback device <NUM> can include a bar code or other code scanner to read the scannable code provided on each strut to determine the strut ID for each strut. In various embodiments, each strut of the external fixator <NUM> can be identified by a separate or unique strut number, or strut ID. In various embodiments, the features of each strut of the external fixator <NUM> used to identify strut ID's for each strut may be coupled to the external fixator <NUM> in various locations and is not necessarily limited to being affixed or adhered to the strut.

<FIG> illustrates a second embodiment of a strut measurement and feedback device <NUM>. The strut measurement and feedback device <NUM> may represent the strut measurement and feedback device <NUM> as depicted in <FIG> and <FIG>. As shown in <FIG>, the strut measurement and feedback device <NUM> is coupled to a strut <NUM>. The strut <NUM> can be a strut of the external fixator <NUM> as depicted in <FIG>.

The strut measurement and feedback device <NUM> may represent an alternative arrangement, form factor, or design of the strut measurement and feedback device <NUM>. In various embodiments, the strut measurement and feedback device <NUM> may include the same or similar components and may provide the same or similar functionalities as the strut measurement and feedback devices <NUM> and <NUM>. As shown in <FIG>, the strut measurement and feedback device <NUM> is positioned over a strut pin <NUM> that can be used to detect an absolute position of the strut <NUM> as described above in relation to the strut measurement and feedback device <NUM>. The strut pin <NUM> can be coupled to an inner rod component <NUM> of the strut <NUM>. The strut <NUM> can further include an outer body component <NUM>.

<FIG> illustrates an example first image <NUM> and an example second image <NUM> that can be captured by a camera of a strut measurement and feedback device (e.g., the strut measurement and feedback device <NUM>, <NUM>, or <NUM>) to detect movement of a strut pin <NUM>. The strut pin <NUM> can be part of or can be coupled to a strut <NUM> (e.g., an inner rod component of a strut). The strut <NUM> can represent a strut of the external fixator <NUM>. Adjacent to the strut pin <NUM> can be a scale <NUM> (e.g., a laser etched graduated scale as described herein). The scale <NUM> can be positioned on a portion of the outer body component of the strut <NUM>.

The first image <NUM> can represent a position of the strut pin <NUM> and the strut <NUM> in a first or initial position. The second image <NUM> can represent a position of the strut pin <NUM> and the strut <NUM> in a second or subsequent position after being moved (e.g., after a length of the strut <NUM> has been adjusted or changed). For each image <NUM> and <NUM>, the strut measurement and feedback device <NUM> can detect an absolute position of the strut <NUM> based on determining a position of the strut pin <NUM> - for example, by comparing a midpoint <NUM> of the strut pin <NUM> to the scale <NUM>. The midpoint <NUM> of the strut pin <NUM> can be determined by image processing or analysis capability of the strut measurement and feedback device <NUM> and/or the user device <NUM>.

The strut measurement and feedback device <NUM> can also detect an amount of movement (e.g., a linear distance measurement) of the strut pin <NUM> (and therefore the strut <NUM>) by determining an adjustment distance <NUM> between a position of the strut pin <NUM> in the first image <NUM> and the strut pin <NUM> in the second image <NUM>. In this manner, the strut measurement and feedback device <NUM> can determine an absolute and/or relative position of each strut of the external fixator <NUM> in real-time as adjustments to the strut <NUM> are made and captured visually.

<FIG> illustrates a third embodiment of a strut measurement and feedback device <NUM>. The strut measurement and feedback device <NUM> may represent the strut measurement and feedback device <NUM> as depicted in <FIG> and <FIG>. As shown in <FIG>, the strut measurement and feedback device <NUM> is coupled to a strut <NUM>. The strut <NUM> can be a strut of the external fixator <NUM> as depicted in <FIG>. The strut <NUM> can include an outer body component <NUM>. Positioned within an interior of the strut <NUM> can be a rod <NUM> (e.g., a threaded rod) that can be moved relative to the outer body component <NUM>.

The strut measurement and feedback device <NUM> can include an ultrasonic measuring device or component to determine a length of the strut <NUM> (and/or a position of the rod <NUM>). As shown in <FIG>, the strut <NUM> can include an opening or window <NUM> that can accept an arm or extension component <NUM> of the strut measurement and feedback device <NUM>. The arm component <NUM> can be positioned within the opening <NUM> and can be oriented or aligned with the open inner interior of the strut <NUM>. The strut measurement and feedback device <NUM> can generate and transmit an ultrasonic signal along the inner portion of the strut <NUM>. The ultrasonic signal can be routed into the interior of the strut <NUM> by the arm component <NUM>.

The ultrasonic signal transmitted by the strut measurement and feedback device <NUM> can reach an end of the rod <NUM> and can then be reflected back toward the arm component <NUM>. The arm component <NUM> can route the reflected signal to an ultrasonic sensor of the strut measurement and feedback device <NUM>. The strut measurement and feedback device <NUM> can then determine a linear distance measurement related to the strut <NUM> and/or the rod <NUM> based on the amount of time between transmitting the ultrasonic signal and receiving the reflected signal. In various embodiments, the position of the rod <NUM> within the strut <NUM> can be determined so as to determine an absolute length of the strut <NUM> and/or the rod <NUM>. The determined measurement and/or position data can then be provided to the user device <NUM>.

In various embodiments, the end of the rod <NUM> can be flat (e.g., as shown in <FIG>). In other embodiments, the end of the rod <NUM> can be have a different shape or geometry such as, for example, spherical to enhance the reflected ultrasonic signal. In various embodiments, the ultrasonic signal can be transmitted, and the reflected signal received, at an end of the arm component <NUM> positioned with the opening <NUM>. Under such scenarios, the ultrasonic sensor may be oriented in line with the inner diameter of the strut <NUM>. In other embodiments, the ultrasonic signal can be transmitted, and the reflected signal received, using ultrasonic deflectors that may be provided within the arm component <NUM> (e.g., as shown in <FIG>). Under such scenarios, the deflectors allow for "bouncing" of the reflected signal at different angles until the reflected signal travels up into the arm component <NUM> and back toward the main body of the strut measurement and feedback device <NUM>.

In various embodiments, as an alternative to transmitting ultrasonic signals for measuring distance and/or position, the strut measurement and feedback device <NUM> can include a laser measurement device or component. The laser measurement component can operate in a similar manner as described above in relation to the ultrasonic measurement component while transmitting and detecting a laser signal reflected off of the rod <NUM>.

<FIG> illustrates a first view of an example embodiment of a strut <NUM>. The strut <NUM> can be a strut of the external fixator <NUM> as depicted in <FIG>. In contrast to current struts, the strut <NUM> can include a strut pin <NUM> that extends beyond an outer perimeter of the strut <NUM> - for example, extending out of a slot <NUM> of the strut <NUM>. As shown in <FIG>, the strut pin <NUM> extends out of the slot <NUM> and wraps around or covers a portion of the outer diameter of the strut <NUM>. By doing so, the strut pin <NUM> allows for a strut measurement and feedback device (e.g., the strut measurement and feedback device <NUM>) to measure movement of the strut pin <NUM> from a fixed attachment point on the strut <NUM>.

Specifically, the strut measurement and feedback device <NUM> can be attached to a fixed position on the strut <NUM> and aimed at the strut pin <NUM>, which acts as a position target. The strut measurement and feedback device <NUM> can be placed on either side of the strut pin <NUM> and can implement any distance measuring technique such as, for example, ultrasonic, laser, or a similar technique to measure the distance to the strut pin <NUM> and/or movement of the strut pin <NUM>.

<FIG> illustrates a second view of the strut pin <NUM> extending from the slot <NUM> of the strut <NUM>. The strut pin <NUM> can be relatively large to provide a large target for the distance measurement component of the strut measurement and feedback device <NUM>, thereby ensuring accurate distance measurements without the need to move the strut measurement and feedback device <NUM> along the length of the strut <NUM>. As shown in <FIG>, the strut pin <NUM> is coupled to an inner rod component <NUM> positioned within an interior of the strut <NUM>.

<FIG> illustrates a fourth embodiment of a strut measurement and feedback device <NUM>. The strut measurement and feedback device <NUM> may represent the strut measurement and feedback device <NUM> as depicted in <FIG> and <FIG>. As shown in <FIG>, the strut measurement and feedback device <NUM> is coupled to a strut <NUM>. The strut <NUM> can be a strut of the external fixator <NUM> as depicted in <FIG>. Positioned within an interior of the strut <NUM> can be a rod <NUM> (e.g., a threaded rod). A strut pin <NUM> can be coupled to the rod <NUM>. The rod <NUM> can be moved relative to an outer body component of the strut <NUM>.

The strut measurement and feedback device <NUM> can include an infrared measuring device or component to determine a length of the strut <NUM> (and/or a position of the rod <NUM>). Similar to the strut measurement and feedback device <NUM>, the strut measurement and feedback device <NUM> can include a portion or component <NUM> positioned within an inner diameter of the strut <NUM>. The infrared measuring component of the strut measurement and feedback device <NUM> can generate and transmit an infrared signal that can be reflected off an end of the rod <NUM> to determine a length of the strut <NUM> and/or a position of the rod <NUM>. As an alternative to using the bottom of the rod <NUM> as the target for the infrared signal, the strut measurement and feedback device <NUM> can be used in conjunction with the enhanced strut pin <NUM> as shown in <FIG> and <FIG> as will be appreciated by one of ordinary skill in the relevant art. In general, the strut measurement and feedback device <NUM> can be attached to a fixed location on the strut <NUM> and can measure a distance to a target - for example, the rod <NUM> - to determine an absolute length of the strut <NUM>.

In an embodiment, the strut measurement and feedback device <NUM> can include a camera that can visualize the threads of a strut of the external fixator <NUM> as the threads turn. Under such a scenario, a window or opening can be provided in the body of each strut of the external fixator <NUM> to provide a view of the threads of the rods. Based on viewing the movement of the threads, the strut measurement and feedback device <NUM> can provide feedback on how far a specific thread has rotated, which can be used to determine a linear distance travelled by the strut given the known pitch of the threaded rod. As a further embodiment, threaded rods of the external fixator <NUM> can include distinguishing features or markings to enable an absolute movement of each strut of the external fixator <NUM> to be determined. The distinguishing features or markings can include features provided directly on the threads. Alternatively, a surface one each rod can be cut down the length of the threaded rod and the surface could be laser marked with numerical lengths or other unique markings.

In a further embodiment, when the strut measurement and feedback device <NUM> includes a camera that can visualize the threads of a strut of the external fixator <NUM>, the strut measurement and feedback device <NUM> can further include or be paired with a position sensor (e.g., a position sensor as described in relation to any of the embodiments described herein). The position sensor can confirm that the strut length is within a general range and the camera can provide additional feedback to the user to define a higher resolution of the position of a strut.

In another embodiment, the strut measurement and feedback device <NUM> can include one or more Hall effect sensors that can be used to determine the length of each strut of the external fixator <NUM>. As an example, a permanent magnet can be attached to a fixed location on a threaded rod within the strut body and one or more Hall effect sensors can be held in stationary positions outside of the strut body. The magnet can move closer or further from the corresponding one or more Hall effect sensors as the rod is moved. The movement of the magnet can be detected by the one or more Hall effect sensors which can determine a linear distance of movement of the strut based on the detected magnetic field changes. In an embodiment, multiple Hall effect sensors can be positioned along the outside of the strut body.

<FIG> illustrates a fifth embodiment of a strut measurement and feedback device <NUM>. The strut measurement and feedback device <NUM> may represent the strut measurement and feedback device <NUM> as depicted in <FIG> and <FIG>. As shown in <FIG>, the strut measurement and feedback device <NUM> is coupled to a strut <NUM>. The strut <NUM> can be a strut of the external fixator <NUM> as depicted in <FIG>.

The strut measurement and feedback device <NUM> may be or may include a membrane potentiometer that can measure the displacement of a pin <NUM> within a slot <NUM> of the strut <NUM>. As shown in <FIG>, the strut measurement and feedback device <NUM> can be attached to the outside of the body of the strut <NUM> at a first position <NUM> and a second position <NUM>. The strut measurement and feedback device <NUM> can be oriented at an angle with respect to the body of the strut <NUM>. In an embodiment, the strut measurement and feedback device <NUM> can be oriented parallel to an axis of the strut <NUM>.

The membrane potentiometer of the strut measurement and feedback device <NUM> can provide a linear measurement based on a voltage output that corresponds to where pressure is applied along the length of the membrane potentiometer. A mechanical or magnetic linkage <NUM> between the pin <NUM> of the strut <NUM> and a pin that applies pressure to the membrane potentiometer would ensure that when the strut pin <NUM> moves, the membrane potentiometer pin also moves along the length of the membrane potentiometer, giving a linear distance measurement. In an embodiment, the strut measurement and feedback device <NUM> can include multiple attachment points to obviate the need for the strut measurement and feedback device <NUM> to cover the entire length of the strut <NUM>. As an example, with two or more attachment points, the strut measurement and feedback device <NUM> can be reduced in length and can be attached to whichever attachment point is closest to the moving pin <NUM> in the slot <NUM> of the strut <NUM>.

<FIG> illustrates a sixth embodiment of a strut measurement and feedback device <NUM>. The strut measurement and feedback device <NUM> may represent the strut measurement and feedback device <NUM> as depicted in <FIG> and <FIG>. As shown in <FIG>, the strut measurement and feedback device <NUM> is coupled to a strut <NUM>. The strut <NUM> can be a strut of the external fixator <NUM> as depicted in <FIG>.

The strut measurement and feedback device <NUM> may be or may include a linear encoder that can be used to measure a length of the strut <NUM>. The linear encoder can be any type of liner encoder including, for example, a magnetic, an optical, an inductive, or a capacitive linear encoder. The linear encoder can include a sensing head that moves along a scale bar. For example, an optical linear encoder can use a light source and a photo-detector to determine the position of the sensing head on the scale bar. A magnetic linear encoder can use a magnetic coupling between the sensing head and a magnetic scale bar. A capacitive or inductive linear encoder can use metal plates embedded in the scale bar that are arranged in a specific pattern that are read by the sensing head.

In general, capacitive and inductive linear encoders can be made with scales that are incremental or absolute. The incremental scales typically have a smaller footprint than the absolute scale. The strut measurement and feedback device <NUM> can be used with either an incremental scale or an absolute scale. An absolute measurement of a length of the strut <NUM> can be made with an incremental scale if a user of the strut measurement and feedback device <NUM> initially slides the strut measurement and feedback device <NUM> to a hard stop at one end of the strut <NUM> to "zero" the linear encoder prior to taking measurements. Alternatively, the user could slide the strut measurement and feedback device <NUM> onto the scale bar in a specific manner every time the strut measurement and feedback device <NUM> is used, such that the linear encoder begins reading the scale bar in the same spot each time it is used.

In an embodiment, to reduce the length of the scale bar that may be required, two attachment points could be used on the strut <NUM>. For example, a first attachment point above a slot of the strut <NUM> can be used with a second attachment point below the slot of the strut <NUM>. The user of the strut measurement and feedback device <NUM> can then attach the strut measurement and feedback device <NUM> to whichever end of the strut <NUM> is closer to a pin positioned in a slot of the strut. In another embodiment, the scale bar could be configured to slide or fold. Accordingly, when the user is measuring shorter struts, the user would not have to fold or slide out the scale bar fully and would only extend the scale fully if the user were measuring relatively longer struts.

<FIG> illustrates several views of the strut <NUM> and a version of the strut measurement and feedback device <NUM> that uses an embedded scale <NUM> that is included into the strut <NUM>. The strut can include a slot <NUM> that can be used to attach the strut measurement and feedback device <NUM> to the strut <NUM>. The strut measurement and feedback device <NUM> can then slide over the embedded scale <NUM>. The strut <NUM> can further include a modified tracking pin <NUM>. The strut measurement and feedback device <NUM> can be coupled or attached either mechanically or magnetically to the modified tracking pin <NUM>. The version of the strut measurement and feedback device <NUM> shown in <FIG> can avoid issues related to the length of the scale and the different lengths of each strut being measured by using, for example, the embedded scale <NUM>.

In an embodiment, the strut measurement and feedback device <NUM> can be coupled to a first feature on a stationary portion of the strut <NUM> (e.g., the outer body of the strut <NUM>) and to a second feature on a translating portion of the strut <NUM> (e.g., the inner threaded rod of the strut <NUM>). Using attachments to the stationary and translating components of the strut <NUM> allows strut measurement and feedback device <NUM> to be used with struts having any length. Any of the described embodiments of the strut measurement and feedback device <NUM> described herein can be modified to use this attachment configuration.

<FIG> illustrates a seventh embodiment of a strut measurement and feedback device <NUM>. The strut measurement and feedback device <NUM> may represent the strut measurement and feedback device <NUM> as depicted in <FIG> and <FIG>. The strut measurement and feedback device <NUM> may be or may include a string potentiometer that can be used to a measure a length of a strut (e.g., a strut of the external fixator <NUM>).

As shown in <FIG>, strut measurement and feedback device <NUM> can include a cable <NUM> (e.g., a string, a wire, or a flexible high strength cable) wrapped around a spool <NUM>. The spool <NUM> can be a constant diameter spool. The spool <NUM> can be spring loaded based on a spring <NUM>. The spring <NUM> can be a high torque, long life power spring. The spool <NUM> can be coupled to a rotational sensor <NUM>.

During operation - for example, when the cable <NUM> extends or retracts - the rotational sensor <NUM> can determine a linear travel distance of the cable <NUM> based on rotation of the spool <NUM>. In various embodiments, the strut measurement and feedback device <NUM> can be coupled to a strut (e.g., a strut of the external fixator <NUM>) such that the spool <NUM> is attached to an outside of the strut and the cable <NUM> is routed through an opening or window in the strut and coupled to a threaded rod of the strut. Accordingly, as the threaded rod is moved, the sensor <NUM> can determine a length of the strut based on the movement of the cable <NUM> and rotation of the spool <NUM>.

In an alternative embodiment, the spool <NUM> can be fixed to the outside of the strut and the cable <NUM> can be attached to a strut pin positioned within a slot of the strut. Overall, the strut measurement and feedback device <NUM> provides for a wide range of mounting and use configurations since the cable <NUM> can be routed around objects and can make <NUM> degree turns.

<FIG> illustrates an eighth embodiment of a strut measurement and feedback device <NUM>. The strut measurement and feedback device <NUM> may represent the strut measurement and feedback device <NUM> as depicted in <FIG> and <FIG>. As shown in <FIG>, the strut measurement and feedback device <NUM> is coupled to a strut <NUM>. The strut <NUM> can be a strut of the external fixator <NUM> as depicted in <FIG>. The strut <NUM> may include a first outer body or member <NUM>, a second outer body or member <NUM>, and an externally threaded rod <NUM> coupled to the first and second outer bodies <NUM>, <NUM>, although the strut may be any suitable strut now known or hereafter developed. A strut pin <NUM> can be used to couple the first outer body <NUM> to the rod <NUM>. Thus arranged, as will be appreciated by one of ordinary skill in the art, rotation of the rod <NUM> causes the second outer body <NUM> to move relative to the first outer body <NUM>.

As further shown in <FIG>, the second outer body <NUM> may be in the form of a first joint <NUM> such as, but not limited to, a universal joint or the like and the first outer body <NUM> may be attached to a second joint <NUM> such as, but not limited to a universal joint or the like. The first joint <NUM> may be attached to a first ring or base of a bone alignment device (e.g., the first ring <NUM> of the bone alignment device <NUM> depicted in <FIG>). The second joint <NUM> may be attached to a second ring or base of a bone alignment device (e.g., the second ring <NUM> of the bone alignment device <NUM> depicted in <FIG>). The strut <NUM> may also include an actuator <NUM> operatively coupled to the first outer body <NUM> and/or the rod <NUM>. In use, rotation of the actuator <NUM> causes the rod <NUM> to rotate to move the first ring or base of a bone alignment device relative to the second ring or base of the bone alignment device, thereby extending or reducing a distance between to the first and second rings of a bone alignment device based on a direction of rotation of the actuator <NUM>.

<FIG> illustrates a detailed, perspective view of an example of an embodiment of a portion of the rod <NUM>. As shown, the rod <NUM> may include threads <NUM> for threadably engaging the first body member <NUM> and a non-circular or cut surface <NUM>. The non-circular surface <NUM> may be a substantially flat surface. The non-circular surface <NUM> may extend the entire length of the rod <NUM>. Alternatively, the non-circular surface <NUM> may extend only a portion thereof. Thus arranged, the rod <NUM> may have a non-circular cross-sectional shape such as, for example, a D-shaped cross-section. As shown, the threads <NUM> may be positioned on an outer portion of the rod <NUM> that has a circular shape.

Referring to <FIG> and <FIG>, an inner diameter of the first outer body <NUM> of the strut <NUM> may include a corresponding non-circular cross-sectional shape as the rod <NUM>, such that the non-circular cross-sectional shape of the rod <NUM> may serve as an antirotational feature to prevent the rod <NUM> from rotating relative to the first outer body <NUM> of the strut <NUM>. In an embodiment, the non-circular cross-sectional shape of the rod <NUM> may be the only anti-rotation feature preventing rotation of the rod <NUM>. In another embodiment, the pin <NUM> may be positioned to ride along a slot formed in the first outer body <NUM> of the strut <NUM> to provide a further anti-rotation mechanism, as described herein. Under either scenario, the rod <NUM> and the first outer body <NUM> of the strut <NUM> may be prevented from rotating relative to each other. As a result, rotation of the actuator <NUM> about the first outer body <NUM> of the strut <NUM> is translated into a translational movement of the rod <NUM> relative to the first outer body <NUM> along a long axis or length of the rod <NUM> and the strut <NUM>.

As shown in <FIG>, the non-circular surface <NUM> of the rod <NUM> may include markings <NUM>. The markings <NUM> may be used to determine and/or indicate a length of the rod <NUM>. In an embodiment, the markings <NUM> may form a measurement scale or may form another pattern for denoting a length of the strut <NUM> (e.g., distance between the second body member <NUM> and the first outer body <NUM>). Referring to <FIG>, the strut measurement and feedback device <NUM> may be operatively coupled to the strut <NUM> and positioned over a slot <NUM> formed in the first outer body <NUM>. The slot <NUM> may be a hole or opening that enables visualization of the markings <NUM> formed on the non-circular surface <NUM> of the rod <NUM>. In an embodiment, the strut measurement and feedback device <NUM> may include a camera or other device to visualize, detect, read, identify, etc. (used interchangeably herein without the intent to limit) the markings <NUM> formed on the non-circular surface <NUM> of the rod <NUM>. Accordingly, as the rod <NUM> is moved relative to the first outer body <NUM> of the strut <NUM>, the strut measurement and feedback device <NUM> may visualize the markings <NUM> and may directly measure the adjusted length of the rod <NUM>.

<FIG> illustrates a top view of the strut measurement and feedback device <NUM> positioned over the slot <NUM> with the strut measurement and feedback device <NUM> shown in transparent form for better clarity. As shown, the strut measurement and feedback device <NUM> can visualize the markings <NUM> formed on the non-circular surface <NUM> of the rod <NUM>.

Referring to <FIG> and <FIG>, the markings <NUM> positioned on the non-circular surface <NUM> allow the strut measurement and feedback device <NUM> to be connected to the strut <NUM> at a fixed location - for example, over the slot <NUM> such that the strut measurement and feedback device <NUM> may always visualize the markings <NUM> as the length of the rod <NUM> is adjusted. This enables a user of the strut measurement and feedback device <NUM> to always attach the strut measurement and feedback device <NUM> to the same location on each strut of a bone alignment device, with such repetition improving usability of the strut measurement and feedback device <NUM> and improving accurate determinations of the length of the rod <NUM>.

In an embodiment, the first outer body <NUM> of the strut <NUM> may include a second slot (not shown) that may aid anti-rotation as described herein - for example, to accommodate use of the pin <NUM>. In general, the first body <NUM> of the strut <NUM> may include any number of slots. The slots can have any width and any length, may have the same or different widths and lengths, and may be positioned along any portion of the body <NUM> of the strut <NUM>. In an embodiment, at least one slot is wide enough for an individual to visualize the markings <NUM> without the use of the strut measurement and feedback device <NUM>.

<FIG> illustrates a ninth embodiment of a strut measurement and feedback device <NUM>. The strut measurement and feedback device <NUM> may represent the strut measurement and feedback device <NUM> as depicted in <FIG> and <FIG>. As shown in <FIG>, the strut measurement and feedback device <NUM> is coupled to a strut <NUM>. The strut <NUM> can be a strut of the external fixator <NUM> as depicted in <FIG>. The strut <NUM> may include a first outer body or member <NUM>, a second outer body or member <NUM>, and an externally threaded rod <NUM> coupled to the first and second outer bodies <NUM>, <NUM>, although the strut may be any suitable strut now known or hereafter developed. Thus arranged, as will be appreciated by one of ordinary skill in the art, rotation of the actuator causes the second outer body <NUM> to move relative to the first outer body <NUM>.

The strut measurement and feedback device <NUM> may include any of the features, capabilities, and/or components of any other strut measurement and feedback device described herein. For example, in an embodiment, the strut measurement and feedback device <NUM> may include the ability to identify a strut (e.g., distinguish the strut <NUM> from any other strut of a bone alignment device) and may include the ability to determine an absolute length of the strut <NUM> (e.g., relative distance between the second outer body <NUM> and the first outer body <NUM>) using any of the features, capabilities, or components described in relation to any other strut measurement and feedback device described herein. Further, as will be described in greater detail below, the strut measurement and feedback device <NUM> may include a device or component for adjusting the length of the strut <NUM> such as, for example, a gear <NUM> for operatively coupling to the actuator and/or threaded rod of the strut <NUM>. In an embodiment, the device for adjusting the length of the strut <NUM> can be permanently attached and/or integrally formed with the strut measurement and feedback device <NUM>. In another embodiment, the device for adjusting the length of the strut <NUM> can be removably attached to the strut measurement and feedback device <NUM>.

<FIG> illustrates a front view of the strut measurement and feedback device <NUM>. <FIG> illustrates a side view of the strut measurement and feedback device <NUM>. <FIG> illustrates a bottom view of the strut measurement and feedback device <NUM>. <FIG> illustrates a top view of the strut measurement and feedback device <NUM>.

<FIG> illustrates a tenth embodiment of a strut measurement and feedback device <NUM>. The strut measurement and feedback device <NUM> may represent the strut measurement and feedback device <NUM> as depicted in <FIG> and <FIG>. As shown in <FIG>, the strut measurement and feedback device <NUM> is coupled to the strut <NUM>.

The strut measurement and feedback device <NUM> may include the same or similar components, may provide the same or similar functionalities, and may operate in a similar manner as the strut measurement and feedback device <NUM>. Accordingly, the strut measurement and feedback devices <NUM> and <NUM> are described herein together for brevity without any intent to limit. Further, as with the strut measurement and feedback device <NUM>, the strut measurement and feedback device <NUM> may identify a strut to which it is attached, determine the absolute length of the strut, and may include a device or may allow a device to be attached that can adjust a length of the strut.

<FIG> illustrates a side view of the strut measurement and feedback device <NUM>. <FIG> illustrates a front view of the strut measurement and feedback device <NUM>. <FIG> illustrates a top view of the strut measurement and feedback device <NUM>. <FIG> illustrates a bottom view of the strut measurement and feedback device <NUM>.

The strut measurement and feedback devices <NUM> and <NUM> may be connected to any portion of a strut such as, for example, strut1802. The strut measurement and feedback devices <NUM> and <NUM> may include a display or screen <NUM>, <NUM> to display identification information of the strut <NUM> and/or to display a measured length of the strut <NUM>. As described herein, each of the strut measurement and feedback devices <NUM> and <NUM> may include a device, an instrument, a component, etc. for adjusting the length of the strut <NUM> or may include the capability to have such device or component removably attached to each of the strut measurement and feedback devices <NUM> and <NUM>. The device for adjusting the length of the strut may be any suitable tool now known or hereafter developed including, for example, a simple mechanical tool, an automated drive tool, an instrument with any combination of electronics, communication interfaces, and strut adjustment schedules stored in a memory, etc..

In one embodiment, a user can couple the strut measurement and feedback devices <NUM> and <NUM> to a strut <NUM>, the strut measurement and feedback devices <NUM> and <NUM> would identify and measure the absolute length of the connected strut <NUM> using any of the mechanism described herein. In addition, the strut measurement and feedback devices <NUM> and <NUM> would adjust the strut to the appropriate length.

In an embodiment, the strut measurement and feedback devices <NUM> and <NUM> may contain electronics (e.g., a controller) and memory (such as the memory <NUM>) that may store length adjustments to be made to a strut such as, for example, strut <NUM> (e.g., as specified by a prescription). The adjustments to the length of the strut <NUM> can then be made automatically based on the stored prescription information. In an embodiment, the strut measurement and feedback devices <NUM> and <NUM> may determine the amount of adjustment required to the strut <NUM> based on a rotary encoder or through real-time measurements of the length of the strut <NUM>. In various embodiments, the strut measurement and feedback devices <NUM> and <NUM> may be attached to a portion of the strut <NUM> that allows the length of the strut <NUM> to be adjusted (e.g., attached to an actuator of the strut <NUM>). In various embodiments, the strut measurement and feedback devices <NUM> and <NUM> may communicate with one or more remote devices such as, for example, wirelessly communicating with a smartphone or other electronic device including, for example, a remote user device or another device that can be used to adjust the length of the strut <NUM> and/or to identify the strut <NUM> or determine the length of the strut <NUM>. In an embodiment, the strut measurement and feedback devices <NUM> and <NUM> may be built into the strut <NUM> as a permanent component rather than being a detachable device. In an embodiment, the strut measurement and feedback devices <NUM> and <NUM> may include a gear <NUM>, <NUM> that interfaces with the actuator and/or threaded rod of the strut <NUM>. In use, rotation of the gear <NUM>, <NUM> causes the threaded rod <NUM> to move the second outer body <NUM> relative to the first outer body <NUM> to adjust the overall length of the strut <NUM>. Rotation of the gear <NUM>, <NUM> may be performed by any suitable mechanism now known or hereafter developed including, for example, hand-rotation, wrench, electronics, etc. In an embodiment, the strut measurement and feedback devices <NUM> and <NUM> may be configured to adjust the length of the strut <NUM> by turning the rod <NUM> directly.

<FIG> illustrates an embodiment of a logic flow <NUM> that may be representative of techniques for providing real-time feedback on the compliance of a length of a strut of an external fixator. The logic flow <NUM> enables an individual adjusting the length of the strut to efficiently determine if the correct strut is being adjusted and if the adjustment matches that specified by a prescription. The logic flow <NUM> may be representative of operations that may be performed by any of the strut measurement and feedback devices with or without corresponding user devices, as described and/or depicted herein. Without the intent to limit, the logic flow <NUM> is described herein with reference to the components of the compliance monitoring system <NUM> as depicted in <FIG>.

At block <NUM>, the strut measurement and feedback device <NUM> can be attached to a strut of the external fixator <NUM>. Prior to being attached or after being attached to the strut of the external fixator, the strut measurement and feedback device <NUM> can determine the strut to which it is attached. Accordingly, the strut measurement and feedback device <NUM> can determine an identification (strut ID) of the strut to which it is coupled. In use, the strut measurement and feedback device <NUM> can determine which strut it is coupled to by any now known or hereafter developed mechanisms including, for example, those described herein. Further, the strut measurement and feedback device <NUM> can provide an indication or signal when the strut measurement and feedback device <NUM> is properly positioned on the strut.

At block <NUM>, the strut measurement and feedback device <NUM> can detect an adjustment made to the length of the strut to which it is attached. The strut measurement and feedback device <NUM> can determine an absolute and/or a relative measurement of the length of the strut. The strut measurement and feedback device <NUM> can determine an initial length of the strut prior to adjustment, an ending length of the strut after the adjustment, and/or a measure of the change in length of the strut resulting from the adjustment. In use, the strut measurement and feedback device <NUM> can determine an adjustment made to the length of the strut by any now known or hereafter developed mechanisms including, for example, those described herein.

At block <NUM>, the strut measurement and feedback device <NUM> can provide any data including, for example, any measurement data determined at block <NUM>, any identification data determined at block <NUM>, etc. to the user device <NUM>. The measurement data can include any type of data including captured image data. The measurement data can be transmitted wirelessly to the user device <NUM>. Alternatively, the measurement data can be transmitted via a wire connected to the user device <NUM>.

At block <NUM>, the strut measurement and feedback device <NUM>, the remote device <NUM>, or the user device <NUM> can compare the measurement data provided by the strut measurement and feedback device <NUM> at block <NUM> to a predetermined prescription for the use of the external fixator <NUM>. The prescription can be stored in memory of the device to perform the comparison such as the memory <NUM> of the strut measurement and feedback device <NUM>, in memory of the remote device <NUM>, and/or in memory on the user device <NUM>. For embodiments in which the user device <NUM> performs the comparison, the user device <NUM> can determine if the adjusted length of the strut matches a prescribed length of the strut. The user device <NUM> can provide real-time feedback to an individual making the adjustments such as one or more indications or signals based on the comparison of the adjusted length of the strut to the proper length of the strut. For example, if the adjusted length matches the proper length, then a first type of indication can be provided by the user device <NUM>. If the adjusted length does not match the proper length, then a second type of indication can be provided by the user device <NUM>. The first and second types of indications can be any combination of visual, audible, or haptic indicators. In other embodiments, the strut measurement and feedback device <NUM> or the remote device <NUM> may perform the comparison and determine if the adjusted length of the strut matches a prescribed length of the strut. In many embodiments, the strut measurement and feedback device <NUM> or the remote device <NUM> may provide real-time feedback to an individual, via the strut measurement and feedback device <NUM> and/or the user device <NUM>, by communicating the results of the comparison and/or providing one or more indications or signals based on the comparison of the adjusted length of the strut to the proper length of the strut.

At block <NUM>, based on the feedback provided by the user device <NUM>, further adjustment can be made to the strut. Alternatively, if the strut length complies with the prescription, then the strut measurement and feedback device <NUM> can be attached to another strut of the external fixator and blocks <NUM>-<NUM> can be repeated.

While the present disclosure refers to certain embodiments, numerous modifications, alterations, and changes to the described embodiments are possible without departing from the sphere and scope of the present disclosure, as defined in the appended claim(s). Accordingly, it is intended that the present disclosure not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims.

Claim 1:
An external bone alignment device (<NUM>) arranged and configured to align two or more bones or pieces of bone, the device comprising:
a first bone coupling device (<NUM>) arranged and configured to engage a patient's first bone or piece of bone;
a second bone coupling device (<NUM>) arranged and configured to engage a patient's second bone or piece of bone;
a plurality of struts (<NUM>, <NUM>) coupled to the first and second bone coupling devices (<NUM>, <NUM>), each of the plurality of struts (<NUM>, <NUM>) being arranged and configured to be lengthened and shortened so that adjustment of the strut (<NUM>, <NUM>) moves the first bone coupling device (<NUM>) relative to the second bone coupling device (<NUM>); and
a strut measurement and feedback device (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) arranged and configured to:
selectively attach to one of the plurality of struts (<NUM>, <NUM>) ; and
provide real-time information regarding an absolute or relative positioning or length of the strut (<NUM>, <NUM>) to which the strut measurement and feedback device (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is attached, the strut measurement and feedback device (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) comprising a strut measurement component (<NUM>) for providing real-time information regarding an absolute or relative positioning or length of the strut to which the strut measurement and feedback device (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is attached,
wherein the strut measurement component (<NUM>) includes a camera (<NUM>) arranged and configured to read visualizing markings positioned on the strut to which the strut measurement and feedback device (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is attached, the visualizing markings determining a length of the strut (<NUM>, <NUM>).