Device for indicating an active component of an adjustable medical instrument

Abstract

An adjustment compliance device and system and method for use with an external fixator are disclosed. The adjustment compliance device can be attached to a strut of the external fixator and can include at least one indicator element to indicate an adjustment parameter of an active step of an adjustment process of the external fixator. The adjustment parameter can include an active strut and / or an adjustment direction of the strut. The adjustment compliance device can receive the adjustment parameter from a user device. The at least one indicator element can include a light element operable to emit light of a color corresponding to the active strut. The at least one indicator element can include a light element configured to indicate a rotation direction of the active strut. As a result, the patient can more effectively comply with the adjustment prescription, thereby increasing the likelihood of successful bone alignment.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 062,080, filed August 6, 2020, entitled “Device for Indicating an Active Component of an Adjustable Medical Apparatus,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to orthotic devices, systems, and methods for facilitating fracture alignment, and more specifically to a device for use with an external fixator to provide real-time indication of the movable strut to be adjusted, thereby ensuring length adjustment according to a predetermined prescription. Background Technology

[0004] Patients who have suffered a fracture may require the use of a bone alignment device or external fixator to align two or more bones or bone fragments. Bone alignment devices typically have multiple struts that need to be adjusted periodically (e.g., daily) according to a prescription. The prescription specifies the strut length adjustments to be made over time to ensure successful bone alignment.

[0005] Typically, patients or healthcare professionals manually adjust the struts of the bone alignment device. Stump adjustment is a challenging and error-prone process that patients often struggle to perform correctly. For example, individuals frequently adjust the struts incorrectly and / or to the wrong length. Adjustments to the struts that are not followed can cause significant frustration in patient care.

[0006] Therefore, it would be beneficial to provide easy-to-use devices, systems, and methods to confirm that the correct support has been adjusted. This disclosure addresses this need. Summary of the Invention

[0007] This summary is provided to introduce, in a simplified form, a series of concepts that will be further described in the detailed description section below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter.

[0008] This disclosure provides an adjustment compliance device. The adjustment compliance device can be attached to the struts of an external fixator. In embodiments, the adjustment compliance device may include at least one indicator element to indicate adjustment information during the adjustment process. In an exemplary embodiment, the adjustment process may include adjusting the struts of the external fixator device according to a hardware adjustment prescription. The prescription may be generated by the patient's surgeon, for example, from surgeon-oriented software. The prescription can then be loaded into the adjustment compliance device.

[0009] In one embodiment, an adjustment compliance device for an adjustable medical device may include: a body having a coupling element for coupling the adjustment compliance device to a portion of the adjustable medical device; a communication interface for communicatively coupling the adjustment compliance device to an external computing device; a logic device configured to receive indicator information from the external computing device; and at least one indicator element disposed on the body, the logic device controlling the at least one indicator element based on the indicator information to indicate at least one adjustment parameter for adjusting the adjustable medical device according to an adjustment prescription.

[0010] In one embodiment, a method for promoting compliance with the adjustment process of an adjustable medical device may include: attaching an adjustment compliance device to a portion of the adjustable medical device, the adjustment compliance device being communicatively coupled to a computing device; generating indicator information via the computing device based on an adjustment prescription; transmitting the indicator information to the adjustment compliance device via the computing device; and controlling at least one indicator element disposed on the adjustment compliance device based on the indicator information to indicate at least one adjustment parameter for adjusting the adjustable medical device according to the adjustment prescription.

[0011] In some embodiments, the at least one indicator element may include a light element operable to be activated to present indicator information. In some embodiments, the indicator information may include adjustment parameters for the current step of the adjustment process. In various embodiments, the adjustment parameters may include a moving part. In some embodiments, the moving part may include a next support to be adjusted for the adjustment process. In an exemplary embodiment, the light element may be activated to emit light corresponding to a color associated with the moving part. In some embodiments, the light element may include a light-emitting diode (LED) light element configured to emit multiple colors of light.

[0012] In some embodiments, the adjustment parameter may include a direction indicator configured to indicate the direction of adjustment of the movable member. In an exemplary embodiment, the direction indicator may indicate that the movable member needs to be rotated clockwise or counterclockwise. In various embodiments, the direction indicator may indicate that the movable member needs to be adjusted by lengthening or shortening it. In some embodiments, the at least one indicator element may include a directional light element operable to indicate the adjustment parameter. In an exemplary embodiment, the directional light element may be configured to indicate the rotation direction of the movable member.

[0013] In an exemplary embodiment, the at least one indicator element may include a series of optical elements. In some embodiments, the series of optical elements may include optical elements for each post of the external fixator.

[0014] In various embodiments, the at least one indicator element may include an audio element configured to provide the adjustment parameters via an audio signal. In some embodiments, the at least one indicator element may include a graphical indicator configured to provide the adjustment parameters via a graphical signal. In various embodiments, the graphical indicator may include a screen for displaying graphical and / or textual information. In an exemplary embodiment, the at least one indicator element may include a haptic or tactile element configured to provide haptic-based or touch-sensitive adjustment parameters.

[0015] In some embodiments, the adjustment compliance device may be or may include a strut measurement and feedback device operable to confirm that it is attached to the appropriate strut to be adjusted. The strut measurement and feedback device can determine whether the strut length adjustment is correct. The strut measurement and feedback device can provide real-time feedback to the individual while the strut length is being adjusted to ensure that the length adjustment conforms to the prescribed strut length. Therefore, by adjusting the strut over time, patients can adhere to the prescription more effectively, thereby increasing the likelihood of successful bone alignment.

[0016] In one embodiment, the adjustment compliance device may include a coupling component, at least one indicator element, and a communication interface. In some embodiments, the adjustment compliance device may further include a support measuring component. The coupling component allows the adjustment compliance device to selectively attach and detach from the support of an external fixator. The support measuring component can determine which specific support the adjustment compliance device is attached to. The support measuring component can also determine the absolute or relative position or length of the support to which the support measuring and feedback device is attached. The communication interface can provide measurement data and identification data about the support to a user device to provide real-time feedback to the individual making the adjustment regarding the support length adjustment. The communication interface can allow the adjustment compliance device to receive indicator information from the user device to operate the indicator element to present the indicator information.

[0017] In one embodiment, the pillar measuring component may include a camera for visualizing markings on the pillar, the camera being used to determine the pillar's movement, position, or length.

[0018] In one embodiment, the pillar measuring component may include a scanner for reading the pillar's barcode to identify the pillar.

[0019] In one embodiment, the pillar measuring component may include a radio frequency identification (RFID) scanner for reading the RFID tag on the pillar used to identify the pillar.

[0020] In one embodiment, the communication interface component may include a wireless communication interface for transmitting measurement data and identification data about the support post to a user device. In another embodiment, the wireless communication interface may be used to receive indicator information from the user device.

[0021] In one embodiment, the support measurement and feedback device may include means for adjusting the length of the support to which the support measurement and feedback device is attached.

[0022] In one embodiment, the means for adjusting the length of the support column is configured to be removably attached to the support column measuring and feedback device.

[0023] The following describes in detail, with reference to the accompanying drawings, at least some of the additional features and advantages of embodiments of the invention, as well as the structure and operation of various embodiments of the invention. Attached Figure Description

[0024] The specific embodiments of the disclosed apparatus will now be described by way of example with reference to the accompanying drawings, in which:

[0025] Figure 1 An example of a first operating environment that may represent some embodiments of this disclosure is shown;

[0026] Figure 2 An embodiment of the bone alignment device is shown;

[0027] Figure 3 A computing device depicting an embodiment of an external fastener adjusting a screen is shown;

[0028] Figure 4 An embodiment of an adjustment compliance system according to one or more features of this disclosure is shown;

[0029] Figure 5 It shows Figure 4 The block diagram shown is of the device for adjusting compliance.

[0030] Figure 6 A block diagram illustrating an embodiment of the compliance adjustment device is shown;

[0031] Figure 7A and 7B A first embodiment of the compliance adjustment device is shown;

[0032] Figure 8A and 8B A second embodiment of the compliance adjustment device is shown;

[0033] Figure 9A and 9B A third embodiment of the compliance adjustment device is shown;

[0034] Figure 10A and 10B A fourth embodiment of the compliance adjustment device is shown;

[0035] Figure 11A and 11B A fifth embodiment of the compliance adjustment device is shown;

[0036] Figure 12A and 12B A sixth embodiment of the compliance adjustment device is shown;

[0037] Figure 13A –13C illustrates a seventh embodiment of a compliance adjustment device;

[0038] Figure 14 An eighth embodiment of the compliance adjustment device is shown;

[0039] Figure 15A and 15B A computing device depicting an embodiment of an external fastener adjusting a screen is shown;

[0040] Figures 16A-16C A screen showing an embodiment of an external fastener adjustment application;

[0041] Figure 17An embodiment of adjusting the excitation screen with an external fixator is shown; and

[0042] Figure 18 The logical flow according to this disclosure is shown.

[0043] The accompanying drawings are not necessarily drawn to scale. The drawings are merely illustrative and not intended to depict specific parameters of this disclosure. The drawings are intended to depict various embodiments of this disclosure and are therefore not to be considered as limiting the scope. In the drawings, the same reference numerals denote the same elements. Detailed Implementation

[0044] For the purpose of promoting understanding of the principles of this disclosure, reference will now be made to the embodiments illustrated in the drawings, and these embodiments will be described using specific language. However, it should be understood that this is not intended to limit the scope of this disclosure in any way. Any changes and further modifications to the described embodiments, as well as any other further applications of the principles of this disclosure described herein, are contemplated by those skilled in the art to which this disclosure pertains.

[0045] Various features of the compliance adjustment system and method will now be described more fully below with reference to the accompanying drawings, in which one or more features of the compliance adjustment system and / or method will be shown and described. It should be understood that the various features can be used independently or in combination with each other. It should be understood that the compliance adjustment system and method disclosed herein can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will convey to those skilled in the art certain characteristic illustrations of the cure status analysis system and method.

[0046] This disclosure generally relates to an adjustment compliance system configured to provide individuals with adjustment information, for example, based on a prescription, to adjust components of an adjustable medical device. In some embodiments, the adjustable medical device may be or may include a bone alignment device, such as an external fixator. In various embodiments, the external fixator may be compatible with the Taylor Spatial Frame manufactured and sold by Smith & Nephew, Inc. of Cordova, Tennessee, USA. TM The systems are identical or substantially similar. In various embodiments, the compliance adjustment system may include compliance adjustment devices configured to provide signals or other indicators to specify which component of an adjustable medical device is active. Generally, the active component is, for example, the component currently designated for adjustment according to a prescription. Typically, this prescription may be generated by a surgeon, for example, from surgeon-oriented software. The generated prescription may be input into the compliance adjustment system.

[0047] For example, in some embodiments, the compliance adjustment device may include a lamp or other element that can be controlled to indicate which strut of the external fastener device is currently designated for adjustment. (Example: Taylor SpatialFrame) TM The external fixator may have multiple supports that require adjustment according to a prescription. Each support may have a color-coded identification band, each band having a unique color and number (e.g., support 1 is "red", support 2 is "orange", support 3 is "yellow", support 4 is "green", support 5 is "blue", and support 6 is "purple"). The adjustment compliance device may be configured to control indicator lights to illuminate in the color corresponding to the active support. For example, if the prescription specifies that support 3 is the next to be adjusted, the light on the adjustment compliance device may illuminate yellow to correspond to support 3. Indicator elements may be activated in response to an action, timing event, or sequence of events of the adjustment compliance device or the adjustment compliance system. As described below, the adjustment compliance device may include other indicator elements, such as a direction indicator configured to indicate the direction of rotation of the active support. Embodiments are not limited to this context.

[0048] Figure 1 An example of an operating environment 100, which may represent some embodiments, is shown. For example... Figure 1 As shown, the operating environment 100 may include a compliance adjustment system 105. In various embodiments, the compliance adjustment system 105 may include a computing device 110, which in some embodiments may be communicatively connected to a network 190 via a transceiver 180. The computing device 110 may be or may include one or more logical devices, including but not limited to server computers, client computing devices, personal computers (PCs), workstations, laptops, notebook computers, smartphones, tablet computers, etc. Embodiments are not limited to this context.

[0049] like Figure 1 As shown, the compliance adjustment system 105 may include or be communicatively coupled to the compliance adjustment device 104. In some embodiments, the computing device 110 may be a smartphone or other mobile computing form factor that is wired or wirelessly connected to the compliance adjustment device 104. For example, the computing device 110 and the compliance adjustment device may communicate via various wireless protocols, including but not limited to Wi-Fi (i.e., IEEE 802.11), radio frequency (RF), and Bluetooth. TM Zigbee TMExamples of such devices include Near Field Communication (NFC) and Medical Implantable Communication Services (MICS). In another example, the computing device 110 and the compliance adjustment device can communicate via various wired protocols, including but not limited to Universal Serial Bus (USB), Lightning, and serial. Although the computing device 110 (and its components) and the compliance adjustment device 104 are depicted as separate devices, the embodiments are not limited thereto. For example, in some embodiments, the computing device 110 and the compliance adjustment device 104 may be a single device. In another example, some or all of the components of the computing device 110 may be included in the compliance adjustment device 104.

[0050] like Figure 1 As shown, patient 150 may be associated with adjustable medical device 160, such as a bone alignment device or external fixator device having multiple components 162a-n (e.g., struts), at least a portion of which may require adjustment. Figure 2 An embodiment of the bone alignment device 200 is shown. In some embodiments, the adjustable medical device 160 may be the same as or substantially similar to the bone alignment device 200. Figure 2 As shown, the bone alignment device 200 can be an external fixator. The bone alignment device 200 may include a first bone connection mechanism, component, device, etc., a second bone connection mechanism, component, device, etc., and multiple interconnected telescopic struts. For example, as... Figure 2 As shown, in one embodiment, the bone alignment device 200 may be formed with six legs having a circular metal frame having six telescopic struts 206 (in Figure 2 The first ring 202 and the second ring 204 are connected by struts 206-1 to 206-6. Each strut 206 can be extended or shortened independently relative to the rest of the frame, thereby allowing six different axes of movement.

[0051] In one embodiment, each strut 206 may include an outer body component and an inner rod component (e.g., a threaded rod). To lengthen or shorten one of the struts 206, the outer body component and the inner rod component can be moved or translated relative to each other. Thus, each strut may be in the form of a telescopic device. Typically, the 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, when the inner rod component translates relative to the outer body component, the strut pin moves in unison with the inner rod component within a slot in the outer body component.

[0052] As will be described herein, the features of this disclosure can be used with any suitable bone alignment device now known or developed hereafter. In this regard, this disclosure should not be limited to this document (e.g., Figure 2Details of the bone alignment device and / or strut disclosed and shown in this disclosure are provided unless expressly required and any suitable bone alignment device may be used in conjunction with the principles of this disclosure.

[0053] The bone alignment device 200 can be used to treat various bone fractures in patients. Typically, the bone alignment device 200 is positioned around the patient and is used to align two or more bones or bone fragments. For this purpose, the length of each strut 206 can be incrementally adjusted (e.g., shortened or lengthened) according to a prescription specifying adjustments to each strut 206 over time to ensure successful bone alignment. In many cases, the length of each strut 206 should be adjusted daily to conform to the provided prescription. Therefore, in use, the prescription may, for example, specify the specific amount of adjustment required, for example, daily, for each strut. In use, the amount of adjustment for each strut can vary daily.

[0054] During manual adjustments, the adjustment of the struts 206 is typically performed directly by the patient or caregiver. For adjustment, the individual can refer to a scale laser-etched onto each strut 206. However, when the bone alignment device 200 is positioned on the patient, the individual making the adjustment may have difficulty visualizing the scale. Additionally, identifying indicators (e.g., strut number and / or color) to recognize the correct active strut is challenging. For adjustment, the individual may also rely on a tactile "click," which the patient can feel when the length of the strut 206 is adjusted by a fixed amount (e.g., 1 mm). However, the tactile click does not indicate the direction in which the strut 206 is being adjusted. Furthermore, individuals may frequently adjust struts incorrectly (e.g., each strut may require a different adjustment amount each day, and the individual may unintentionally adjust the wrong strut or adjust the correct strut by the wrong amount). Moreover, an individual may unintentionally rotate one or more struts in the wrong direction, thereby shortening the strut instead of lengthening it, for example. Therefore, despite the implementation of safeguards such as rulers, tactile clicks, and color labels, individuals may find it difficult to confirm that the correct pillars are being adjusted and / or that the appropriate length of each pillar 206 as specified in the prescription is being achieved when adjusting the pillars 206. Consequently, individuals often do not comply with the prescription when adjustments are made.

[0055] Patients typically undergo follow-up visits, for example, every two weeks, so that their clinicians can assess the patient's progress and modify the bone alignment device 200 or related prescriptions as needed. Incorrect adjustments to the strut 206 that may occur between visits can lead to a significant deviation of the bone segment's alignment path from the prescription, resulting in a significant setback in the patient's treatment.

[0056] refer to Figure 1The compliance adjustment device 104 may include one or more indicators 112a-n, operable to indicate the movable component 162a-n (e.g., the next support to be adjusted according to the prescription). In various embodiments, the indicators 112a-n may be configured to notify other information besides or alternative to the movable component 162a-n, such as the direction of rotation of the movable support. The indicators 112a-n may include various elements capable of providing information to the user, including but not limited to lights, graphical user interface (GUI) devices, audio devices, haptic devices, etc.

[0057] For example, indicator 112a may be or may include a lamp or group of lamps that can be activated to display different colors. For example, indicator 112a may include one or more light-emitting diode (LED) lamps capable of emitting light of a color corresponding to the color of a specified pillar. In some embodiments, the lamp may include an incandescent light element, a gas discharge light element, a halogen light element, a CFL light element, or other light elements now known or developed in the future.

[0058] For example, if the support column 1 is in an active state, indicator 112a may emit red light. In another example, indicator 112n may be configured to indicate the direction of rotation of the support column 1 (e.g., based on prescription information 142 and / or status information 144, as described below). For example, indicator 112n may be configured to present an arrow, rotating light, or graphic and / or other signal to indicate the direction of rotation of the support column. Thus, in one embodiment, if the prescription specifies that the current step requires adjustment of the support column 1 such that the support column 1 needs to be rotated clockwise, indicator 112a may emit red light, and indicator 112n may indicate clockwise rotation. As described in more detail in this disclosure, indicators 112a-n may include various other types of signal elements associated with various other indicator information 146.

[0059] The computing device 110 may include processor circuitry 120, which may include and / or have access to various logic for performing processes according to some embodiments. For example, processor circuitry 120 may include and / or have access to adjustment logic 130 and / or adjustment indicator logic 132. Processing circuitry 120, adjustment logic 130 and / or adjustment indicator logic 132 and / or portions thereof may be implemented in hardware, software or a combination thereof. As used herein, the terms “logic,” “component,” “layer,” “system,” “circuit system,” “decoder,” “encoder,” “control loop,” and / or “module” are intended to refer to computer-related entities, which may be hardware, a combination of hardware and software, software, or software in execution. For example, logic, circuit systems, or modules can be and / or may include, but are not limited to, processes running on a processor, processors, hard disk drives, multiple storage drives (of optical and / or magnetic storage media), objects, executable files, execution threads, programs, computers, hardware circuit systems, integrated circuits, application-specific integrated circuits (ASICs), programmable logic devices (PLDs), digital signal processors (DSPs), field-programmable gate arrays (FPGAs), system-on-a-chip (SoCs), memory cells, logic gates, registers, semiconductor devices, chipsets, microchips, chipsets, software components, programs, application programs, firmware, software modules, computer code, control loops, computational models or application programs, AI models or application programs, ML models or application programs, proportional-integral-derivative (PID) controllers, FG circuit systems, variations thereof, combinations of any of the above, and so on.

[0060] Although adjusting logic 132 is in Figure 1 The embodiment is depicted as being within processor circuitry 120, but the embodiment is not limited thereto. For example, adjustment logic 130, adjustment indicator logic 132, and / or any component thereof may be located within an accelerator, processor core, interface, single processor chip, or implemented entirely as a software application (e.g., adjustment application 148), etc.

[0061] Memory cell 140 may include various types of computer-readable storage media and / or systems in the form of one or more high-speed memory cells, such as read-only memory (ROM), random access memory (RAM), dynamic RAM (DRAM), dual data rate DRAM (DDRAM), synchronous DRAM (SDRAM), static RAM (SRAM), programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory, polymer memory such as ferroelectric polymer memory, austenite memory, phase change or ferroelectric memory, silicon-oxide-nitride-oxide-silicon (SONOS) memory, magnetic or optical cards, device arrays such as redundant array of independent disks (RAID) drives, solid-state storage devices (e.g., USB storage, solid-state drives (SSDs), and any other type of storage media suitable for storing information. Additionally, memory cell 140 may include various types of computer-readable storage media in the form of one or more low-speed memory cells, including internal (or external) hard disk drives (HDDs), floppy disk drives (FDDs), optical disk drives that read from or write to removable optical disks (e.g., CD-ROMs or DVDs), solid-state drives (SSDs), etc.

[0062] According to some embodiments, memory unit 140 may store various types of information and / or applications for adjusting the compliance process. For example, memory unit 140 may store prescription information 142, status information 144, indicator information 146, and / or adjustment application 148. In some embodiments, prescription information 142, status information 144, indicator information 146, adjustment application 148, and / or portions thereof may be stored in one or more data memories 192a-n, which are accessible by computing device 110 via network 190.

[0063] In some embodiments, the adjustment application 148 may be or may include an application executing on the computing device 110 (including a mobile application or "application" executing on the mobile device form factor). In various embodiments, the adjustment application 148 may be or may include iADJUST provided by Smith & Nephew, Inc. of Cordova, Tennessee, USA. TM Applications on the same or similar platforms.

[0064] In some embodiments, prescription information 142 may include a prescription for adjusting the adjustable medical device 160. For example, the prescription may specify adjustments to components 162a-n based on a schedule (e.g., on day X, support 1 should have (or should be moved a certain distance in a specified direction) a length Y, support 2 should have (or should be moved a certain distance in a specified direction) a length Z, and so on). Status information 144 may include the status of components 162a-n, such as the status of active components (e.g., the next component to be adjusted), current position (e.g., length), last rotation direction, etc. For example, status information 144 may include the current length of each support.

[0065] In various embodiments, indicator information 146 may include information that can be used to facilitate compliance with adjustment components 162a-n. For example, indicator information 146 may include active components 162a-n (i.e., the next support to be adjusted), adjustment directionality, adjustment amount, etc. For example, a prescription may specify that support 1 should be moved to position X. Adjustment application 148 may access status information 144 to determine the current position of support 1 to determine the desired direction of rotation (e.g., clockwise to lengthen and counterclockwise to shorten, or vice versa). Active support (i.e., support 1) and / or directionality may be specified as indicator information 146, which is provided to adjustment compliance device 104 to provide the user with indications of active components 162a-n and other adjustment parameters (e.g., the direction of rotation of the active support).

[0066] In some embodiments, as described in more detail below, the compliance adjustment system may include a measurement and feedback device 116. In various embodiments, the measurement and feedback device 116 may be coupled to each strut at a time. In use, in one embodiment, the strut measurement and feedback device 116 may determine which strut the strut measurement and feedback device 116 is coupled to and may provide real-time feedback on the position of each strut (e.g., the absolute position of each strut may be determined, which can then be used to determine the length change experienced by the strut by, for example, comparing the starting position with the ending position). Non-limiting examples of measurement and feedback devices are described in International Application No. PCT / US2020 / 015558 entitled “Device for External Fixation Strut Measurement and Real-Time Feedback,” which is incorporated herein by reference as fully set forth.

[0067] Using the measurement and feedback device 116 requires the user to place it on the correct support. However, placing the measurement and feedback device 116 on the correct support can be challenging when adjustments are made. Currently, the user must consult the display device 182 to determine which support the measurement and feedback device 116 should be placed on. However, according to some embodiments, the adjustment compliance device 104 and / or the measurement and feedback device 116 implementing the adjustment compliance function can mitigate or even eliminate such challenges by clearly and easily indicating to the user which support the measurement and feedback device 116 is connected to directly on the measurement and feedback device 116 (e.g., reducing the need for repeated checks between the bone alignment device and the calculation device 110).

[0068] In various embodiments, the compliance adjustment system 105 may include an adjustable medical device 160, which may be configured as an autoadjustment device 118, configured to automatically adjust the adjustment of components 162a-n or auxiliary components 162a-n (e.g., by providing feedback or other information). In some embodiments, the autoadjustment device 118 may be or may include a component, tool, device, or other element attached to the adjustable medical device 160 (e.g., attached to one of components 162a-n, such as a strut) but not making adjustments (e.g., providing feedback to the user or other device for adjustment). In other embodiments, the autoadjustment device 118 may be or may include a tool that adjusts, for example, based on feedback from a measurement and feedback device 116. Non-limiting example embodiments of the autoadjustment device 118 are described in U.S. Provisional Patent Application No. 62 / 906,298, entitled “Motorized Auto-Adjusting External Fixation System,” which is incorporated herein by reference as if fully set forth herein.

[0069] Although the compliance adjustment device 104, the measurement and feedback device 116, and the automatic adjustment device 118 are in Figure 1 While depicted as a single device, embodiments are not limited thereto, as the adjustment compliance device 104 may be or may include measurement and feedback device 116, automatic adjustment device 118, and / or components thereof. For example, measurement and feedback device 116 (or automatic adjustment device 118) may include indicators 112a-n and may provide the compliance functions described with respect to the adjustment compliance device 104 in this disclosure. In some embodiments, automatic adjustment device 118 and / or components thereof may be coupled to, integrated into, embedded in, or otherwise integrated with the adjustable medical device 160.

[0070] In some embodiments, the measuring and feedback device 116 may use a camera to identify the current length of the support using markings on it, and transmit that length back to the adjustment application 148 in real time. Thus, the user can see, for example, the current support length relative to the prescription, displayed via the display device 182. However, placing the measuring device on the correct support remains challenging when making adjustments. For example, the user may have to observe the display 182 to determine which support to place the measuring device on, indicated by the color and number used to identify the support. For example, each support has an identification band with color and number that the user must match. The lack of additional indications to identify supports creates a risk that the user may place the measuring and feedback device 116 on the wrong support. Therefore, the adjustment compliance device 104 may operate to mitigate this risk and promote compliance by providing signals to the user via indicators 112a-n that indicate the active support, adjustment direction, and / or other adjustment information.

[0071] For example, adjustment logic 130, implemented via adjustment application 148 executed by processor circuitry 120, is operable to perform an adjustment compliance process to facilitate appropriate adjustments of the adjustable medical device 160 by the user according to the prescription specified in prescription information 142. Adjustment logic 130 may operate alone or in combination with adjustment indicator logic 132. The user may initiate the adjustment process, for example, via a graphical user interface (GUI) presented on display device 182. Figure 3 A computing device is shown illustrating an embodiment of an external fastener adjusting a screen. (As shown) Figure 3 As shown, the computing device 310 can present an adjustment screen 320 for a bone adjustment device having supports 1 (306-1) to 6 (306-6). The adjustment screen 320 may include additional information such as support status 330 (i.e., active, completed, error, etc.), adjustment value (i.e., adjusted support length) 334, and current value (i.e., current support length) 336. In status 305A, support 1 306-1 is an active support. The adjustment logic 130 may specify indicator information 146 that support 1 306-1 is an active support, such as active component parameters. The adjustment compliance device 104 may receive the indicator information 146 and activate the indicator 112a to notify support 1 306-1 that it is an active support (support 1 is associated with red) by illuminating a red indicator light on the adjustment compliance device 104.

[0072] Adjustment logic 130 can determine in which direction the support 1 306-1 must be rotated to achieve the adjustment value 334 of the support 1 306-1. For example, the current value 336 (i.e., length) of the support 1 306-1 may be less than the adjustment value 334 (i.e., the specified support length for the adjustment event) of the support 1 306-1, indicating that the support 1 306-1 needs to be lengthened. Adjustment logic 130 can determine indicator information 146, such as adjustment parameters associated with lengthening the support 1 306-1, for example, that the support 1 306-1 needs to be rotated in a certain direction (e.g., clockwise or counterclockwise) to achieve the adjustment value 334. Adjustment compliance device 104 can receive the adjustment parameters and activate indicators 112a-n that notify the type of adjustment of the moving part (e.g., clockwise rotation).

[0073] When support 1 306-1 has been properly adjusted, the status 330 of support 1 306-1 can be updated to indicate that the adjustment of support 1 is complete, such as by user selection and / or by automatic indication via measurement and feedback device 116 and / or automatic adjustment device 118, and screen 320 can transition to status 305B of support 2. Therefore, adjustment logic 130 can operate to facilitate the transmission of updated indicator information 146 to adjustment compliance device 104, specifying support 2 306-2 as the active support and / or associated adjustment parameters.

[0074] In some embodiments, the process of adjusting the bone alignment device using the adjustment compliance device 104 may include an adjustment application 148 wirelessly transmitting the color of the support to which the adjustment compliance device 104 should be placed to the adjustment compliance device via a computing device 110. The adjustment measuring device may activate an indicator element 112a (i.e., a light element) to emit light corresponding to the indicated color to match the color of the active support. The user may attach the adjustment compliance device 104 (and / or the measurement and feedback device 116, which may be an integral part of the adjustment compliance device 104) to the active support. The user may adjust the support and remove the adjustment compliance device 104 from the support, repeating this process for each additional support.

[0075] Figure 4 An embodiment of a compliance monitoring system 400 for use in conjunction with an external fixation system to monitor support compliance is illustrated. The compliance monitoring system 400 may include an external fixator 402, a compliance adjustment device 404, and a user device 406. In various embodiments, the external fixator 402 may be… Figure 2 The bone alignment device 200 is depicted in the figure. Alternatively, the external fixator 402 may be any other bone alignment device now known or developed in the future.

[0076] In use, the compliance adjustment device 404 can be selectively attached to each post of the external fixator 202 (see example). Figure 7A , 8A (9A, 10A, 11A, 12A and / or 13A). In one embodiment, the adjustment compliance device 404 can be coupled to each support at a time. In use, in one embodiment, the adjustment compliance device 404 can provide real-time information indicating which support is the active support that needs adjustment. This real-time feedback can notify the user device 406 to facilitate the user in adjusting the correct supports in a specified order according to a predetermined prescription.

[0077] As described in more detail in this disclosure, in use, the compliance adjustment device 404 can take any of many different forms. The compliance adjustment device 404 can perform one or more of the following features, alone or in conjunction with the measurement and feedback device 116 and / or the automatic adjustment device 118, etc.: collecting data, processing data, transmitting data, receiving data, and / or providing feedback. For example, in some embodiments, the compliance adjustment device 404 can perform all of these features. Alternatively, in some embodiments, the compliance adjustment device 404 can collect data and transmit the data to, for example, a user device 406, which can process the data and / or provide feedback. With this arrangement, in use, the compliance adjustment device 404, alone or together with the measurement and feedback device 116, the automatic adjustment device 118, and / or the user device 406, can determine / detect which specific support (e.g., support 106-1 or 106-2, 106-3, etc.) is connected to, and determine whether it is properly attached to the support (e.g., indicating whether the compliance adjustment device 406, the measurement and feedback device 116, and / or the automatic adjustment device 118 are correctly attached). The system can detect the initial position (e.g., initial length of the support) of the support, detect the adjusted position (e.g., adjusted length of the support) and / or determine changes in the length of the support, transmit data to, for example, user device 406, receive data (e.g., prescription, indicator information) from, for example, user device 406, store the patient's prescription to adjust the position of each support, compare data including the adjusted length or adjusted position of the support with the prescription, check prescription compliance, provide feedback or indications on compliance and / or non-compliance, etc.

[0078] The compliance adjustment device 404, measurement and feedback device 116, and / or auto-adjustment device 118 can communicate directly or indirectly with user device 406, which can be any suitable user device now known or developed in the future, including, for example, electronic devices and / or computing devices, such as smartphones, tablets, laptops, notebooks, netbooks, personal computers (PCs), etc. In various embodiments, the compliance adjustment device 404, measurement and feedback device 116, and / or auto-adjustment device 118 and user device 406 can communicate via any known wired or wireless communication standards or protocols. Exemplary wireless connections and / or protocols may include, for example, Wi-Fi (e.g., any IEEE 802.11a / b / g / n network), Bluetooth, Bluetooth Low Energy (BLE), Near Field Communication (NFC), any cellular communication standard, any infrared communication protocol, USB, Lightning, etc.

[0079] The communication connection between the compliance adjustment device 404 and the user device 406 enables data or information, such as measurement data, support identification data, compliance data, indicator information, status information, etc., determined by the compliance adjustment device 404, to be provided to the user device 406 for user review.

[0080] like Figure 4 As also shown, user device 406 can communicate directly or indirectly with one or more remote computing devices, remote computer networks and / or remote cloud networks or platforms 408 (collectively, “remote devices 408”, without limitation). Real-time data, including, for example, measurement data, monitoring data, etc., provided to user device 406 and / or vice versa by compliance adjustment device 404, measurement and feedback device 116 and / or automatic adjustment device 118, can be relayed to remote device 408. This enables telehealth providers (HCPs) to monitor patient adherence to pre-prescriptions in real time. In embodiments, real-time measurement and / or compliance data, which may be determined by compliance adjustment device 404, measurement and feedback device 116 and / or automatic adjustment device 118, can be provided to one or more remote devices 408 after the supports of external fixator 402 have been adjusted or after all supports have been adjusted. Alternatively, real-time measurement and / or compliance data, which may be determined by the compliance adjustment device 404, the measurement and feedback device 116, and / or the automatic adjustment device 118, may be provided in real time to one or more remote devices 408 (e.g., when any support is being adjusted), thereby allowing the remote HCP to interact directly with the individual making the adjustment through communication with the user device 406.

[0081] In various embodiments, the user device 406 may include software or an application (e.g., a “mobile application” or “application”) that receives real-time data (e.g., measurement data, compliance data, indicator information, etc.) determined by the adjustment compliance device 404, the measurement and feedback device 116, and / or the automatic adjustment device 118. The application on the user device 406 may provide feedback to the individual adjusting the external fixator 402 during adjustments. The feedback can be any type of feedback and may include, for example, visual, tactile, and / or auditory feedback. Feedback provided by the user device 406 based on real-time measurement and / or compliance data determined by the support measurement and feedback device 404 can increase the likelihood of appropriate adjustments to the external fixator and / or adherence to the prescription. In various embodiments, the capabilities, features, and / or functions of user device 406, as well as the capabilities, features, and / or functions of any software or application provided on user device 406, can be described in U.S. Patent Application Publication No. 2016 / 0092651, filed May 14, 2014, entitled “Apparatus and Method for Administering a Medical Device Prescription,” which is incorporated herein by reference in its entirety.

[0082] Prescriptions or portions thereof for movement of the struts of the external fixator 402 may be stored remotely (e.g., on one or more remote devices 408) and / or on the user device 406. Real-time measurement and / or compliance data, status information, indicator information, etc., determined by the adjustment compliance device 404, measurement and feedback device 116, and / or automatic adjustment device 118, may be compared with locally or remotely stored prescriptions to provide feedback to the individual adjusting the struts of the external fixator 402. Therefore, feedback provided to the individual adjusting the external fixator 402 may be generated remotely (e.g., by one or more remote devices 408) and transmitted to the user device 406, or may be generated locally (e.g., by an application running on the user device 406).

[0083] The communication connection between the patient, the individual adjusting the external fixator 402, and the remote HCP, enabled by the compliance monitoring system 400, allows for the sharing of additional data or information. In various embodiments, visual, text, and / or voice data or other information can be shared between the user device 406 and the remote computing device 408. In this way, the patient, the HCP, and / or other individuals adjusting the external fixator 402 can communicate with the remote HCP or other individuals while adjustments are in progress or at any other time. In various embodiments, the patient connected to the external fixator 402 can transmit information related to pain or any other discomfort to the remote HCP. In various embodiments, the remote HCP can modify the prescription for the use of the external fixator 402 and transmit it to the user device 406 for storage and / or use.

[0084] Figure 5 An embodiment of the compliance adjustment device is shown. Specifically, Figure 5 A block diagram of a circuit 500 interconnecting the functional components of an adjustment compliance device 504 is provided. As shown, the adjustment compliance device 504 may include a coupling member or module 502 for selectively coupling and detaching the adjustment compliance device 504 from a support post. The coupling member 502 may provide one or more physical mechanisms for coupling and disconnecting the adjustment compliance device 504 from a support post of an external fastener (e.g., 200 or 402). The coupling member 502 may include one or more mechanical components, electrical components, electromechanical components, or any combination thereof.

[0085] The compliance adjustment device 504 may include a support measuring component, module, or logic 530. In some embodiments, the support measuring component 530 enables the compliance adjustment device 504 to determine the absolute and / or relative positioning of the support to which the compliance adjustment device 504 is attached. The support measuring component 530 may also determine which particular support the compliance adjustment device 504 is attached to. The support measuring component may include one or more mechanical components, electrical components, electromechanical components, or any combination thereof. In some embodiments, the compliance adjustment device 504 may include component indicator logic 532 operable to perform, support, or otherwise facilitate a compliance adjustment process according to various embodiments. For example, according to some embodiments, the indicator logic 532 may control the operation of input / output device 512 (e.g., emitting light) to indicate the component to be adjusted, the direction of adjustment, and / or other adjustment information.

[0086] The compliance adjustment device 504 may include a wireless communication interface 506, which is operable to provide an interface for communicating with any local or remote device or network via any wireless communication technology. The wireless communication interface 506 enables the compliance adjustment device 504 to directly or indirectly wirelessly transmit and receive data or information with the user device 406 and / or one or more remote computing devices 408.

[0087] The compliance adjustment device 504 may include one or more input / output devices or components 512 operable to provide visual, auditory, and / or tactile feedback to a user of the compliance adjustment device 504. In some embodiments, the input / output device 512 may be or may include indicator elements 112a-n. In various embodiments, the input / output device 512 may include one or more speakers, one or more light-emitting diodes (LEDs), haptic devices, and / or displays (e.g., touchscreens). In some embodiments, the input / output device 512 may include a reader device configured to read corresponding elements on a post to determine a post identifier. For example, the input / output device 512 may include a camera (e.g., identifying color stripes or numbers on a post), a radio frequency identification (RFID) scanner for reading RFID tags located on a post, a near field communication (NFC) reader, a QR code reader, a barcode reader, etc. In this way, the input / output device 512 is operable to determine which post the compliance adjustment device 504 is attached to. In various embodiments, the input / output device 512 may indicate to the user of the compliance device 504 whether the compliance device 504 is being used correctly (e.g., if the compliance device 504 is attached correctly or incorrectly) and / or may indicate whether the strut measurement is in progress, completed, and / or completed incorrectly or erroneously.

[0088] The compliance adjustment device 504 may include a power source 510, which may be or may include a power connection and / or a battery. The power source 510 may supply power to… Figure 5 The power source 510 is powered by any of the constituent functional components of the compliance adjustment device 504 depicted. In various embodiments, the power source 510 may be a rechargeable battery or, alternatively, a replaceable battery. In some embodiments, the power source 510 may be or may include an external power source, such as a mobile computing device (e.g., via USB or Thunderbolt), an external battery, a power outlet, etc.

[0089] The compliance adjustment device 504 may further include processor circuitry 520 and an associated memory unit 530. The memory unit 530 may store one or more programs executed by the processor circuitry 520 to implement one or more functions or features of the compliance adjustment device 504 as described herein. The processor circuitry 520 may be implemented using any processor or logic device. The memory unit 530 may be implemented using any machine-readable or computer-readable medium capable of storing data, including volatile and non-volatile memory.

[0090] The processor circuit 520 can achieve Figure 5 The function of any component depicted, or the ability to control or adjust the operation of any depicted component. Figure 5 Each component depicted may be coupled to processor circuitry 520 and any other depicted components. For example, in some embodiments, processor circuitry 520 may determine, for instance, indicator information transmitted via user device 506 and store the indicator information in memory 540. In some embodiments, indicator information may include a movable support and / or information for adjusting the rotational direction of the movable support. In various embodiments, processor circuitry 520 may determine whether adjustment compliance device 504 is communicating with user device 506 and may accordingly activate / deactivate connection indicator input / output device 512. The depicted components may be implemented in hardware or software, or any combination thereof, as appropriate.

[0091] Figure 6 A block diagram illustrating an embodiment of the compliance adjustment device is shown. Figure 6 As shown, the compliance adjustment device 604 may include a body or housing 610 associated with one or more input / output elements 612a-g. In some embodiments, some of the input / output elements 612a-g may be or may include indicator elements configured to present indicator information to a user. For example, indicator element 612a may indicate the power status of the compliance adjustment device 604, such as whether the compliance adjustment device 604 is powered on, charging, etc. Indicator element 612b may serve as a communication status indicator to indicate whether the compliance adjustment device 604 is properly communicating via a specific protocol (e.g., Bluetooth, WiFi, etc.) and / or with a device (e.g., user device 406).

[0092] The indicator element 612c may be a component indicator operable to indicate a moving part in the adjustment process. In various embodiments, the indicator element 612c may provide a signal specifying a moving part. For example, the indicator element 612c may be a light element configured to emit light having a color corresponding to a moving post of the bone adjustment device (e.g., red light for post 1). In another example, the indicator element 612c may include a set of light elements, one light for each part, configured to emit light from the light element corresponding to the moving part (e.g., light 3 for post 3). In some embodiments, the set of light elements may include a row or a ring of colored light (e.g., one light for each post). For example, a mechanism having a light source and a series of colored media can be used to indicate a moving part, the colored media rotating in front of the light source to change the color of the light projected from the device.

[0093] In another example, indicator element 612c may include a screen device (LCD, etc.) configured to display information indicating the active component (e.g., support number, support position, support color, etc.) and / or other information, including but not limited to, current support length, required support length, adjustment direction, overshoot / undershoot, support identification, battery status, wireless connection status, wired connection status, support adjustment reminder, support replacement notification, errors, diagnostic information, total adjustment, etc.

[0094] In another example, indicator element 612c may include a speaker device configured to provide an audible signal, such as the name of the projected moving part, a series of tones associated with the moving part, and / or other information, including but not limited to, where the support will be attached, step-by-step indication for applying and using the measuring device, current support length, required support length, adjustment direction, overshoot / undershoot, support identification, battery status, wireless connection status, wired connection status, support adjustment reminder, support replacement notification, errors, diagnostic information, total adjustment, etc. Embodiments are not limited to this context.

[0095] Indicator element 612d can be used as an adjustment direction indicator, for example, to specify the direction of rotation of the strut or whether the strut needs to be lengthened or shortened. For example, indicator element 612d may include a rotating pattern, circular beam, rotating beam, etc., configured to emit light in a manner indicating the direction of rotation. In another example, indicator element 612d can be activated to indicate that the movable strut should be adjusted to lengthen or shorten the strut. For example, if the strut 1 of the bone applicator needs to rotate clockwise, indicator element 612c can be activated to indicate that strut 1 is a movable part, and indicator element 612d can be activated to indicate clockwise rotation.

[0096] Indicator element 612e can be operated to indicate an error state of adjustment compliance device 604. For example, adjustment compliance device 604 may receive erroneous or undecipherable adjustment information, making it impossible for adjustment compliance device 604 to determine adjustment parameters, such as the active support, rotation direction, etc. In some embodiments, adjustment compliance device 604 may determine which component it is connected to and which component is the active component (or this information may be received from user device 406). If adjustment compliance device 604 determines that it is connected to an incorrect component during adjustment (i.e., a support that is not the active support), adjustment compliance device 604 may activate an error condition. Indicator element 612e can be activated to notify the user of a signal indicating an error condition (and, in some embodiments, the type of error condition). In various embodiments, an accompanying error message may be displayed on user device 406.

[0097] In some embodiments, one or more of the indicator elements 612a-g may include tactile or haptic indicator elements configured to indicate indicator information, including but not limited to moving parts, adjustment direction, current measurement reading, support to be attached, step direction for applying and using the measuring device, etc.

[0098] In various embodiments, one or more input / output devices may be separate from the body 610 of the compliance device 604. In various embodiments, the second housing or body 630 may contain one or more input devices 612f and / or components (e.g., hardware and / or software elements) of the compliance device 604. In some embodiments, the input / output element 612g (e.g., a camera) may be a single element disposed outside the main housing 610. In some embodiments, external components such as 630 and 612g may be connected to the main housing 610 via connector element 622. In some embodiments, connector element 622 may include communication elements, such as wires, which may be used to transmit communication signals, data, power, etc., between the external components and the main housing 610.

[0099] The compliance adjustment device 604 may include one or more coupling elements 602a-n to attach, secure, mount, engage, or otherwise connect the main housing 610 to an adjustable medical device and / or its components, such as the strut of a bone adjustment device. Coupling elements 602a-n may include clips, C-clamps, clamps, pendants, hooks, loops, rings, hooks, snap-fit ​​elements, friction-fit elements, etc. In various embodiments, components external to the main body 610 (e.g., elements 630 and 612g) may include their individual coupling elements 602p, 602q.

[0100] This document describes various embodiments of the compliance adjustment device. These embodiments can vary in shape, size, function, form factor, and / or other characteristics. Furthermore, the various embodiments can be implemented, for example, regarding... Figure 1 , 2 and Figure 4-6 The components described differ. Features and / or functions of any described embodiment may be combined or used in combination with features and / or functions of any other embodiments described herein, as will be understood by those skilled in the art.

[0101] Figure 7A and 7B A first embodiment of the compliance adjustment device is shown. Figure 7A As shown, the medical adjustment device may include a bone alignment device 760 attached to a portion of the patient 752 (e.g., a portion of the lower leg bone). In some embodiments, the bone alignment device 760 may include a... Figure 2 The bone alignment device 760 is the same as or similar to the bone alignment device 200. In some embodiments, the bone alignment device 760 may be a Taylor Spatial Frame. TM Device. In various embodiments, the bone alignment device 760 may include a plurality of struts 762a-c. Although Figure 7A The diagram shows three pillars, but according to some embodiments, the bone alignment device 760 may include more or fewer pillars.

[0102] The compliance adjustment device 704 may include a body 710 that houses a power button 740 to enable / disable the compliance adjustment device 704. An indicator element (or lamp) 712 may include a light element configured to emit light of a different color corresponding to the active supports 762a-c. For example, support 762a (e.g., support 5) is associated with a blue band. The compliance adjustment device 704 may cause the indicator element 712 to emit blue light to indicate that support 762a is active. In various embodiments, the compliance adjustment device 704 may include, for example, a coupling member 702 in the form of a clip, configured to attach the compliance adjustment device 704 to a portion of the supports 762a-c. In some embodiments, the compliance adjustment device 704 is operated (see, for example...). Figure 4 At least a portion of the required hardware and / or software may be arranged within the main body 710.

[0103] Figure 7B Various views of the adjustment compliance device 704 are shown, such as top perspective view 770, top view 771, rear (or connecting side) view 772 and side view 773.

[0104] Figure 8A and 8BA second embodiment of the compliance adjustment device is shown. (As shown) Figure 8A As shown, the compliance adjustment device 804 may include a body 810, a power button 840, and an indicator element 812 configured to emit light corresponding to the color of the active supports 762a-c. The compliance adjustment device 804 may include a second housing 830 connected to the support 762a via a coupling member 802. In some embodiments, the second housing 830 may include at least a portion of the hardware and / or software required to operate the compliance adjustment device 804. For example, the second housing 830 may include a camera or other means for operating the compliance adjustment device 804. The body 810 and the second housing 830 may be connected, for example, via a communication element 822, forming a wired connection.

[0105] Figure 8B Various views of the adjustment compliance device 804 are depicted, such as top perspective view 870, top view 871, front view 872, and side view 873. Referring to front view 872, in some embodiments, the adjustment compliance device 804 may include a port 826 for, for example, charging and / or communicating with the adjustment compliance device 804. For example, port 826 may include a Lightning port or a mini or micro USB port for charging the adjustment compliance device 804 and / or connecting the adjustment compliance device 804 to the user device 406.

[0106] Figure 9A and 9B A third embodiment of the compliance adjustment device is shown. (As shown) Figure 9A As shown, the compliance adjustment device 904 may include a body 910, a power button 940, and an indicator element 912 configured to emit light corresponding to the color of the active supports 762a-c. The compliance adjustment device 904 may include a second housing 930 connected to the support 762a via a coupling member 902b. The body 910 may include the coupling member 902a, for example in the form of a hook or hook-like element, configured to allow the body 910 to suspend on the frame portion 936 of the bone alignment device 760. The body 910 and the second housing 930 may be connected via a communication element 922, for example, forming a wired connection.

[0107] Figure 9B Various views of the compliance adjustment device 904 are depicted, such as top perspective view 970, top view 971, front view 972, and side view 973. Figure 9B As shown, the connecting member 902a may be formed of a hook portion 950 (e.g., formed of a strong, non-flexible material such as metal) and a resilient door portion 952.

[0108] Figure 10A and 10BA fourth embodiment of the compliance adjustment device is shown. (As shown) Figure 10A As shown, the compliance adjustment device 1004 may include a body 1010, a power button 1040, and an indicator element 1012 configured to emit light corresponding to the color of the active supports 762a-c. The body 1010 may be connected to the support 762a, for example, via a coupling member 1002, which may be in the form of a snap-fit ​​clip arranged on the rear side of the body 1010.

[0109] Figure 10B Various views of the compliance adjustment device 1004 are depicted, such as top perspective view 1070, top view 1071, front view 1072 and side view 1073.

[0110] Figure 11A and 11B A fifth embodiment of the compliance adjustment device is shown. (As...) Figure 11A As shown, the compliance adjustment device 1104 may include a body 1110, a power button 1140, and an indicator element 1112 configured to emit light corresponding to the color of the active supports 762a-c. The compliance adjustment device 1104 may include a second housing 1130 connected to the support 762a via a coupling member 1102b (e.g., a snap-fit ​​clip). The body 1110 may include the coupling member 1102a configured to releasably engage an opening 1138 in the frame 1136 of the bone alignment device 760. The body 1110 and the second housing 1130 may be connected, for example, via a communication element 1122, forming a wired connection. In some embodiments, the second housing 1130 may include at least a portion of the hardware and / or software required to operate the compliance adjustment device 1104.

[0111] Figure 11B Various views of the compliance adjustment device 1104 are depicted, such as top perspective view 1170, top view 1171, front view 1172, and side view 1173. Figure 11B As shown, the connecting member 1102a may be formed of one or more posts 1142 configured to engage an opening 1138 in the frame 1136 of the bone alignment device 760. For example, a first portion 1143 of the post 1142 may be forced into the opening 1138 to position the post 1142 within the opening 1138. The post 1142 and / or portions thereof may be formed of a flexible material configured to facilitate gripping of the interior portion of the opening 1138 by the post 1142.

[0112] Figure 12A and 12B A sixth embodiment of the compliance adjustment device is shown. (As shown) Figure 12AAs shown, the compliance adjustment device 1204 may include a clip connection member 1202 that connects a portion of the compliance adjustment device 1204 to the support column 762a (i.e., the movable support column). The compliance adjustment device 1204 may include a user device 1206, such as a smartphone or other mobile computing device, operable to perform the functions of the compliance adjustment device 1104, such as instructing the movable support column, adjusting parameters, etc. In some embodiments, at least a portion of the functions of the compliance adjustment device 1204 may be performed via hardware and / or software arranged in the connection member 1202. For example, the connection member 1202 may include a camera device, an optical element, etc. In various embodiments, the connection member 1202 and the user device 1206 may be connected, for example, via a communication element 1222, forming a wired connection.

[0113] Figure 12B Various views of the connecting component 1202 are shown, such as top perspective view 1270, top view 1271, front view 1272, and side view 1273. Figure 12B As shown, the connecting member 1202 may include a pair of forks 1242, which can be squeezed to unfold the clamp portion 1244 to engage around a portion of the support column 762a-c; the release of the forks 1242 may allow the clamp portion 1244 to retract around the support column 762a-c to rigidly attach the connecting member 1202 to the support column 762a-c.

[0114] Figures 13A-13C A seventh embodiment of the compliance adjustment device is shown. (As shown) Figures 13A-13C As shown, the compliance adjustment device 1104 may include a body 1310 that houses a power button 1340 and indicator elements 1312a, 1312b. Indicator element 1312a may be operable to indicate a moving part, such as the next strut to be adjusted for the bone alignment device. For example, indicator element 1312a may be a light element configured to emit light corresponding to the color of the moving strut. Indicator element 1312b may be, for example, a power status indicator indicating the charging level of the compliance adjustment device 1304.

[0115] In some embodiments, the compliance adjustment device 1304 may include, for example, a hook-shaped coupling member 1302a operable to suspend from the frame of the bone alignment device or otherwise support the body 1310. The compliance adjustment device 1304 may include a second housing 1330 having an indicator element 1312c. For example, the indicator element 1312c may be a light element configured to emit light corresponding to the color of the active support. The second housing 1330 may include a coupling member 1302b operable to attach the second housing 1330 to the support of the bone alignment device. The second housing 1330 may be communicatively coupled to the body 1310, for example, via a communication element 1322, forming a wired connection. In some embodiments, at least a portion of the hardware and / or software for operating the compliance adjustment device 1304 may be arranged within the second housing 1330.

[0116] Figure 14 An eighth embodiment of the compliance adjustment device is shown. Figure 14 The diagram shows a front open view 1470, a front closed view 1471, and a rear closed view 1472 of the adjustment compliance device 1404. In some embodiments, the adjustment compliance device 1404 may include a power button 1440 and indicator elements 1412a and 1412b. Indicator element 1412a may be operable to indicate a moving part, such as the next strut to be adjusted for the bone alignment device. For example, indicator element 1412a may be a light element configured to emit light corresponding to the color of the moving strut. Indicator element 1412b may be a power status indicator, for example, indicating the charging level of the adjustment compliance device 1404.

[0117] The compliance adjustment device 1404 may include a connecting member 1402 in the form of a hook or loop, configured to suspend the compliance adjustment device 1404 to a portion of the bone alignment device, such as a frame portion, or otherwise support the compliance adjustment device. In some embodiments, the connecting member 1402 may be flexible to allow an opening to unfold to engage around a portion of the bone alignment device, such as a frame portion, and then return to its original position. As shown in views 1471 and 1472, the connecting member 1402 can be moved to a closed position when not in use.

[0118] Figure 15A and 15B A computing device is shown illustrating an embodiment of an external fastener adjusting a screen. (As shown) Figure 15AAs shown, user device 1510 may present adjustment screen 1520 for automatically adjusting the support using measurement and feedback device 116 and / or automatic adjustment device 118. Adjustment screen 1520 may present active support 1530, adjustment information 1532, adjustment status 1534, and / or a graphical representation of the support (e.g., markings on the support for position information). In some embodiments, adjustment information 1532 may include adjustment value 1531 (i.e., the length of the adjusted support) and current value 1533 (i.e., the current length of the support). In status 1520, adjustment of support 3 has begun, and the length 1533 of support 3 needs to be lengthened to meet adjustment value 1531. In status 1521, support 3 is too long, resulting in "Too Long" status 1534 and an indicator showing that the length of support 3 needs to be reduced. In status 1522, support 3 has been adjusted to meet adjustment value 1531, and a "Support 3 Complete" message is presented in status 1534.

[0119] refer to Figure 15B In state 1523, adjusting screen 1520 can display the next pillar to be adjusted. Figure 15B It has been adjusted to meet adjustment value 1531. In state 1524, all pillars have been adjusted for prescription adjustment events (e.g., daily adjustments), and the completed status screen 1540 can be presented via user device 1510.

[0120] Figures 16A-16C An embodiment of the screen for adjusting the external fastener is shown. Typically, Figures 16A-16C This illustration depicts a pediatric version of an external fixator adjustment application configured to present animations, GUI objects, rewards, incentives, and / or other elements to provide a positive user experience for pediatric patients and their caregivers. (See also:) Figure 16A As shown, the external fixator adjustment application may include a home screen 1602, which is displayed when the external fixator adjustment application is launched on the user's device. From the home screen 1602, the user can navigate to a reward screen 1604 and / or access a prescription screen 1606. From the prescription screen 1606, the user can launch a manual prescription screen 1608, for example, for manually adjusting the struts of the bone alignment device.

[0121] refer to Figure 16B The illustration shows, for example, an automatic adjustment screen 1610 for implementing a prescription using a measurement and feedback device 116 and / or an automatic adjustment device 118. A completion animation screen 1612 may be displayed to complete the prescription using pillar adjustment and / or manual and / or automatic adjustment methods. Reference Figure 16CError screen 1614 may be presented in response to the detection of one or more error conditions, such as over-adjustment of the support, loss of communication between the user device and the adjustment compliance device, measurement and feedback device, and / or automatic adjustment device. One or more prescription completion screens 1616 may be presented in response to determining that the patient has completed the prescription.

[0122] Figure 17 An embodiment of an external fixator adjustment incentive screen is shown. In some embodiments, the external fixator adjustment application may provide certain incentives, rewards, or other behavior-based information to enhance the user experience and / or promote appropriate prescription adherence. Figure 17 Screens 1620-1623 are shown, depicting various behavior-based or incentive-based information used to promote user compliance with prescriptions for external fixator adjustment applications.

[0123] This document includes one or more logical flows representing exemplary methods for performing novel aspects of the disclosed architecture. While for the purpose of simplicity of explanation, one or more methods illustrated herein are shown and described as a series of actions, those skilled in the art will understand and recognize that the methods are not limited to a specific order of actions. Accordingly, some actions may occur in a different order and / or concurrently with other actions shown and described herein. For example, those skilled in the art will understand and recognize that the methods may alternatively be represented as a series of interrelated states or events, such as in a state diagram. Furthermore, new embodiments may not require all the actions shown in the methods.

[0124] The logical flow can be implemented in software, firmware, hardware, or any combination thereof. In software and firmware embodiments, the logical flow can be implemented by computer-executable instructions stored on a non-transitory computer-readable medium or a machine-readable medium. Embodiments are not limited to this context.

[0125] Figure 18 An embodiment of logic flow 1800 is illustrated. Logic flow 1800 may represent some or all of the operations performed by one or more embodiments described herein. In some embodiments, logic flow 1800 may represent some or all of the operations of an adjustment process according to some embodiments.

[0126] At block 1802, logic flow 1800 may access a prescription. For example, computing device 110 may access prescription information 142, which may specify a prescription for adjusting the struts of the bone alignment device. Logic flow 1800 may determine moving parts at block 1804. For example, adjustment application 148 may determine the next strut to be adjusted according to the prescription. At block 1806, logic flow 1800 may determine indicator information. For example, adjustment application 148 may determine adjustment information 146 associated with adjusting the moving strut, such as color, numbers, or other symbols associated with the moving strut and / or the direction of adjusting the strut (e.g., lengthening / shortening, clockwise / counterclockwise rotation, etc.).

[0127] The logic flow 1800 may present adjustment indicators at block 1808. For example, the adjustment application 148 may provide information, instructions, etc., to the adjustment compliance device 104 to activate one or more indicators 112a-n to notify the user of adjustment information. For example, if the support 1 is active, the adjustment compliance device 104 may activate indicator 112a to emit light corresponding to the color of the band on the support 1. In another case, if the support 1 needs to be rotated clockwise, for example, to lengthen the support 1, the adjustment compliance device 104 may activate indicator 112n to indicate clockwise rotation of the support 1. The user may connect the adjustment compliance device 104 (and / or the measurement and feedback device 116 and / or the automatic adjustment device 118) to the support indicated by indicator 112a, for example, to ensure that the correct support is being adjusted.

[0128] At box 1810, logic flow 1800 can determine whether the adjustment of the moving part is complete. During manual adjustment, this can be based on selecting the completed object on the screen (see example...). Figure 3 The system determines that the adjustment of the moving part is complete, and the completion object indicates that the user has completed the adjustment of the moving support. In automatic or measurement / feedback-based adjustment processes, the completion of the adjustment of the moving part can be determined based on feedback from the measurement and feedback device 116 and / or the automatic adjustment device 118 (e.g., see...). Figure 15A and 15B If the adjustment of the active component is complete, logic flow 1800 can determine at box 1812 whether all components have been adjusted. If additional components need adjustment, logic flow 1800 can identify the active component at box 1804. If all components have been adjusted, logic flow 1800 can determine at box 1814 that the adjustment process is complete.

[0129] While this disclosure sets forth certain embodiments, many modifications, alterations, and variations of the described embodiments are possible without departing from the field and scope of this disclosure as defined in the appended claims. Therefore, it is intended that this disclosure be limited to the described embodiments but have the full scope defined by the language of the following claims and their equivalents. The discussion of any embodiments is intended to be illustrative only and is not intended to imply that the scope of this disclosure (including the claims) is limited to these embodiments. In other words, while illustrative embodiments of this disclosure have been described in detail herein, it should be understood that the inventive concept can be practiced and used in other ways, and the appended claims are intended to be construed as including such variations unless limited by prior art.

[0130] The foregoing discussion has been presented for purposes of illustration and description and is not intended to limit this disclosure to one or more of the forms disclosed herein. For example, for the purpose of simplifying this disclosure, various features of this disclosure have been grouped together in one or more embodiments or constructions. However, it should be understood that various features of certain embodiments or constructions of this disclosure may be combined in alternative embodiments or constructions. Furthermore, the following claims are hereby included, by reference, in this detailed description, wherein each claim is an independent embodiment of this disclosure.

[0131] As used herein, an element or step described in the singular and preceded by the word "a / an" should be understood to not exclude a plurality of elements or steps unless such exclusion is explicitly stated. Furthermore, references to "one embodiment" in this disclosure are not intended to be construed as excluding the existence of additional embodiments that also include the described features.

[0132] As used herein, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions for combining and separating in operation. The terms “a” (or “one type”), “one or more,” and “at least one” are used interchangeably herein. All directional references (e.g., near, far, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, and counterclockwise directions) are used only for identification purposes to aid the reader’s understanding of this disclosure and do not impose limitations, particularly regarding the location, orientation, or use of this disclosure. Unless otherwise stated, connection references (e.g., joining, attaching, linking, connecting, and combining) should be interpreted broadly and may include intermediate members between sets of elements as well as intermediate members that move relative to the elements. Thus, a connection reference does not necessarily infer that two elements are directly connected and have a fixed relationship with each other. All rotational references describe relative movement between various elements. Identification references (e.g., first, second, first, second, third, fourth, etc.) are not intended to imply importance or priority but are used to distinguish one feature from another. The accompanying drawings are for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the accompanying drawings may vary.

Claims

1. An adjustment compliance device for an adjustable medical device, comprising: A main body having connecting elements for connecting the adjustment compliance device to a portion of the adjustable medical device; A communication interface for communicatively connecting the compliance adjustment device to an external computing device; A logic device configured to receive indicator information from the external computing device; At least one indicator element is disposed on the main body, and the logic device controls the at least one indicator element based on the indicator information to indicate at least one adjustment parameter for adjusting the adjustable medical device according to an adjustment prescription; The at least one indicator includes a light element operable to be controlled to emit light to indicate a moving part, the light element being configured to emit light corresponding to a color associated with the moving part.

2. The adjustable compliance device according to claim 1, wherein the adjustable medical device includes an external fixator.

3. The adjustment compliance device according to claim 1 or 2, further comprising a second housing connected to the support of the adjustable medical device via the coupling element; and in, The main body and the second housing are connected via a communication element.

4. The compliance adjustment device according to claim 1 or 2, wherein the at least one adjustment parameter includes the orientation of the movable part of the adjustable medical device.

5. The adjustment compliance device according to claim 2, wherein the connecting element includes at least one of a clip or a hook, the clip releasably clamping the adjustment compliance device to a post of the external fixator, and the hook suspending the adjustment compliance device from the frame of the external fixator.

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