Improved programmable tool for external fixation strut adjustment

Abstract

The present disclosure relates to a tool for adjusting an external fixation strut having an adjustment mechanism for length adjustment and a second connection portion, the tool comprising: a first connection portion adapted to perform data communication with the external fixation strut via the second connection portion; and a controller including command instructions. Based on the command instructions, the controller is configured to: download prescription data from the external unit, the prescription data relating to the determined condition of the patient and including instructions for performing adjustments to an external fixation strut of the patient; entering a waiting state in which the controller waits for coupling with an external fixation strut of the patient to communicate data therewith via the first connection portion; after the tool is coupled with the external fixing supporting column, the coupling state of the tool and the external fixing supporting column is distinguished; based on the coupling, communicating with an external stationary strut via a first connection portion; and, once the coupling is completed and the data with the external stationary strut has been exchanged, waiting for the date and / or time to apply the prescribed adjustment based on the prescription data. Related external fixation struts and related medical assemblies are also disclosed.

Description

Technical Field

[0001] The present disclosure relates to the field of external fixation and, more particularly, to the operation of a tool for incrementally or decrementally adjusting the struts of an external fixator, especially during the postoperative period. The following description pertains to this technical field and is intended only to simplify its exposition. Background Art

[0002] Without limiting the scope of the present disclosure, the background of the present disclosure is described in connection with external fixation devices and related tools for adjusting their struts or other connecting rods.

[0003] Generally, external fixation devices are commonly used in various surgical procedures, including limb fracture fixation, lengthening, and deformity correction. The process involves applying a rigid frame consisting of several rings or arches that are placed around the outside of the limb and attached to bone segments using wires and half-pins inserted into the bone segments and connected to relevant parts of the external rigid frame.

[0004] The rings of the rigid frame that are located opposite each other are directly interconnected by threaded and / or telescopic struts, or interconnected in combination with single-plane or multi-plane hinges, which allows for longitudinal, rotational, horizontal, or angular adjustment of the position of the rings relative to each other over a period of time.

[0005] For example, in limb lengthening, the bone is surgically divided into two segments, and wires and half-pins are inserted into the bone segments above and below the surgical bone incision and attached to rings of the rigid frame that are interconnected by struts or telescopic connecting struts.

[0006] For limb lengthening, the opposite rings are preferably directly interconnected by at least three or four threaded or telescopic struts, the lengths of which are regularly adjusted and allow the bone segments to be gradually separated longitudinally.

[0007] The rigid frame is used to gradually push the two bone segments longitudinally apart over a period of time (e.g., one millimeter per day). This allows new bone to gradually form in the gap between the bone segments created by this distraction technique. Once the desired amount of lengthening (e.g., 5 - 6 centimeters) is achieved, the external device is stabilized in a fixed position and left on the bone segments until the newly formed bone is fully mineralized (e.g., 3 - 6 months, depending on the nature of the pathology and / or the amount of lengthening).

[0008] Similarly, in deformity correction, the bone is surgically divided into two segments (usually at the apex of the deformity), and wires and half-pins are inserted into the bone segments above and below the surgical bone incision and attached to the rings of the rigid frame. In this case, the opposite rings of the rigid frame are also connected together by threaded struts with attached hinges and an angular distractor that is used to gradually separate the two bone segments at an angle over a period of time.

[0009] A common fixation device is a circular metal structure known as the Ilizarov device. When used for limb lengthening or deformity correction, the Ilizarov device consists of several rings or arches that are placed externally around the limb and attached to surgically separated bone segments using wires and half-pins. For angular deformity correction, the opposing rings of the Ilizarov device are connected by a pair of hinges and an angular distractor, the pair of hinges providing an axis of rotation for the bone segments, and the angular distractor gradually pushing the two rings and associated bone segments apart.

[0010] Another common external fixation device is called the Taylor Spatial Frame, which is a hexapod external fixation device based on the so-called Stewart platform but shares many components and features with the Ilizarov device.

[0011] The Taylor Spatial Frame consists of two external fixation rings that are attached to bone segments using wires and half-pins and are connected together by six telescopic struts with multi-planar hinges at each end of the struts. Each strut can be lengthened or shortened as needed to pull the two interconnected ring segments closer together or push them apart.

[0012] Other examples of such external fixation devices are commercially known as TrueLok and Sheffield.

[0013] Adjusting the strut lengths allows for acute or gradual manipulation of the bone segments about several axes to sequentially or simultaneously lengthen the limb and correct angular, translational, and rotational deformities.

[0014] The daily strut length adjustments are typically calculated by dedicated software. Once the device is attached to the bone segments, many parameters such as deformity parameters, frame parameters, mounting parameters, etc. are input into the software to characterize the position of one ring relative to another and the position of the bone segments relative to each other and relative to the rings. After calculating the total amount of each strut length adjustment, the software provides a tabular instruction (termed a "prescription") regarding the amount of each strut length adjustment that should be achieved with each increment, including the number identifying the individual strut, the amount of adjustment required, and the scheduled time for such adjustment. In most cases of deformity correction, the struts are adjusted in different directions (shortening / lengthening) and by different amounts.

[0015] Since the prescription needs to be adjusted several times over time, typically up to four times a day, in most cases these adjustments cannot be performed by the surgeon or a dedicated physician. Thus, the task of following the prescription is delegated to the patient or one of their relatives, who accomplish this by turning the adjustment knobs on the struts or by turning the nuts on threaded rods or telescopic rods using a wrench.

[0016] This way of adjusting the strut length is time-consuming (e.g., because the threaded rod nuts need to be loosened and retightened before and after each adjustment), does not provide precise length adjustment (e.g., because it is difficult to monitor small adjustment amounts), and causes instability of the overall frame during adjustment (e.g., because of the dimensional gaps between the connecting elements).

[0017] In addition, the prescription for length adjustment may be complex and is prone to human error during the execution of complex prescriptions. Even if the patient is required to verify the compliance between the prescription and the frame condition by checking the strut length, errors may still go unnoticed due to oversight or complete lack of inspection.

[0018] In addition, it must be taken into account that the feedback to the surgeon depends on the patient, and the patient is usually required to convey the adjustments made to the struts by uploading information on a dedicated portal. Again, patient negligence may result in incorrect or incomplete information being given to the surgeon.

[0019] It is easy to understand that errors during the execution of the prescription, especially if not recognized by the surgeon in a timely manner, may have an adverse impact on the final outcome of the correction process.

[0020] To alleviate the above-mentioned drawbacks, a programmable tool has been proposed in recent years for gradually adjusting the length of the struts of an external fixator. This tool (e.g., described in the prior art application WO 2009 / 105479 under the name of Texas Scottish Rite Hospital for Children) is designed as an electric wrench for engaging with the adjustment mechanism of the external fixator strut. The tool has an internal memory for storing the adjustment parameters of the prescription and is set to automatically adjust each strut according to the said parameters.

[0021] Although this programmable tool offers many advantages compared to the prior art discussed above, it still has drawbacks, especially those related to the ease of use of the device.

[0022] In fact, in order to correctly adjust the length parameters of the struts according to the memorized prescription, it is recommended to feed the tool with real-time measurements of the strut length. If the tool makes an incremental or decremental change in length according to the prescription without feedback, the adjustment process may be prone to problems due to incremental errors, and any incorrect operation by the patient (e.g., coupling the tool to the wrong strut when applying the prescription) may interfere with the correct implementation of the adjustment plan over time.

[0023] Accordingly, the programmable tool is preferably provided with means for measuring the length of the struts, such as a digital ruler adapted to be coupled to its opposite ends. However, such measuring means increase the complexity of the device and, more importantly, they require active patient action, thus making the process of applying the prescription more difficult and prone to human error.

[0024] It has been observed that alternative ways of measuring the length of the struts (e.g., via sensors built into the struts themselves) have so far been ruled out because it is difficult to power the internal sensors and transmit the sensor signals to the tool. In particular, due to practical design issues and regulatory compliance, wireless methods are difficult to implement, while adding a wired plug seems impractical both in terms of product design and usability.

[0025] Moreover, the programmable tool preferably requires additional interface means, such as means for identifying the individual struts, to assist the patient in correctly performing the prescription. This means can be, for example, an RFID reader for reading the unique identification code on the strut. However, this increases the complexity and leaves a certain degree of uncertainty in the process, as the patient may erroneously skip the step of identifying the strut, or correctly identify the strut and then erroneously apply the prescribed length increment or decrement to an adjacent strut.

[0026] Accordingly, with known solutions, the interaction between the tool, the struts to be adjusted, and the patient is cumbersome and may lead to operating errors. Therefore, it is desirable to provide a system for adjusting external fixation struts to address or at least mitigate the deficiencies identified in the prior art.

[0027] The technical problem to be solved by the present invention is to design a tool for adjusting external fixation struts, which has functional and structural features to allow overcoming the limitations and drawbacks of prior art solutions, in particular having an improved interaction with the external fixation strut(s) such that the external fixation strut can be operated efficiently while enabling the adjustment process to be automated / secured without burdening the user with additional tasks such as strut number identification or external measurement of the strut length, and without resorting to wireless data communication between the adjustment tool and the strut, thereby avoiding adjustment errors. Summary of the Invention

[0028] The solution idea underlying the present disclosure is to provide a programmable tool adapted to be coupled to one or more struts of an external fixation device and capable of exchanging operation data (and delivering power to the struts) with said struts, e.g., to receive data from sensors of the struts (e.g., position sensors) and use said data with the aid of an integrated controller that automatically drives the programmable tool to adjust the external fixation struts.

[0029] More particularly, the tool of the present disclosure has an innovative interaction with an external fixation strut and is configured to automatically retrieve from a cloud unit the prescription associated with the patient for the tool (including the date and / or time of subsequent adjustment steps and possibly generate reminders), and also obtain feedback information (such as the actual length of the strut) based on data communication with the strut, and the adjustment is then automatically performed after connecting to the strut based on the downloaded prescription and the feedback information. First, the operator (e.g., a surgeon) pairs the tool with each strut after downloading the prescription data, so that each strut is uniquely associated with the tool (with a unique strut ID) due to data communication with each strut and can thus be distinguished by the tool. Then, the patient is correctly guided through all the operation steps, and he / she only needs to press the button of the tool to confirm and / or initiate a specific operation of the tool and perform the adjustment operation, and since the surgeon has previously performed the association of the struts, an error message is generated if the wrong strut is engaged.

[0030] Based on this solution concept, the above technical problem is solved by a tool for adjusting an external fixation strut, which has an adjustment mechanism for length adjustment and a second connection part, and the tool includes:

[0031] - A first connection part adapted to perform data communication with the external fixation strut via the second connection part; and

[0032] - A controller, which includes command instructions and, based on the command instructions, is configured to:

[0033] - Download prescription data from an external unit, the prescription data being related to the determined situation of the patient and including instructions for performing adjustments on the patient's external fixation strut;

[0034] - Enter a waiting state, in which the controller waits to be coupled (i.e., preliminarily coupled) with the patient's external fixation strut in order to transmit data with it via the first connection part; the download of the prescription and the preliminary coupling can generally be performed by a surgeon (or any other suitable operator);

[0035] - After the tool is coupled with the external fixation strut, distinguish the coupling state with the external fixation strut (i.e., distinguish the coupling between the tool and the external fixation strut);

[0036] - Based on the coupling state, communicate with the external fixation strut via the first connection part; and

[0037] Once the coupling is completed and data has been exchanged with the external fixation strut, wait for the date and / or time to apply the prescribed adjustment based on the prescription data.

[0038] More particularly, the present disclosure includes the following additional and optional features, which may be employed individually or in combination with each other.

[0039] According to one aspect of the present disclosure, during initial coupling, the controller may be configured to assign a strut ID to an external fixation strut.

[0040] According to one aspect of the present disclosure, the prescription data may include a set of dates and / or times for successive adjustments to be applied to the external fixation strut, and the prescription data may include the degree of adjustment to be applied.

[0041] According to one aspect of the present disclosure, the controller may be configured to generate a reminder when a prescribed adjustment date and / or time is reached.

[0042] According to one aspect of the present disclosure, the state in which the controller waits for a date and / or time for a prescribed adjustment to be applied may be an idle state.

[0043] According to one aspect of the present disclosure, when a date and / or time for strut adjustment to be applied is reached, the controller may be configured to enter a further waiting state, in which the controller waits for successive coupling (i.e., another coupling after initial coupling) in order to apply a prescribed adjustment to the external fixation strut, the successive coupling involving mechanical engagement with the external fixation strut. The successive coupling may be performed by the patient.

[0044] According to one aspect of the present disclosure, after mechanical engagement with the external fixation strut during the successive coupling operation after the further waiting state, the controller may be configured to apply a prescribed adjustment by a drive tool member adapted to act on an adjustment mechanism of the external fixation strut.

[0045] According to one aspect of the present disclosure, during the successive coupling operation, the controller may be configured to retrieve information related to the external fixation strut from the external fixation strut, wherein the information includes at least a measurement indicating the length of the external fixation strut, the length being used for feedback control of the drive tool according to the prescription data. Obviously, the surgeon may also read the length of the strut during initial coupling.

[0046] According to an embodiment, the information may also include the strut ID.

[0047] According to one aspect of the present disclosure, the controller may be configured to retrieve a measurement indicating the length of the external fixation strut from a sensor of the external fixation strut, the data passing through a first connection portion.

[0048] According to one aspect of the present disclosure, the controller may be configured to detect an update of the prescription data from an external unit and download the update in order to replace the previously downloaded prescription data with the updated prescription data.

[0049] According to one aspect of the present disclosure, the controller may be configured to postpone applying an adjustment to an external fixed strut after a user's selection.

[0050] According to one aspect of the present disclosure, in the case where the user selects to postpone, the controller may be configured to apply the postponed adjustment to the strut during the next adjustment operation, and the amount of adjustment added during the next adjustment operation is based on the time elapsed since the last performed adjustment operation.

[0051] According to one aspect of the present disclosure, the tool may include a push button adapted to be engaged by a user to initiate or complete or select an operating step of the tool.

[0052] According to one aspect of the present disclosure, the tool may include a component for transmitting data to an external unit.

[0053] According to one aspect of the present disclosure, after completing the coupling (preliminary coupling and sequential coupling) with one external fixed strut, the controller may be configured to check whether the tool is to be coupled to other external fixed struts, and if so, then enter a waiting state, where the controller waits for the coupling with the other external fixed struts.

[0054] According to one aspect of the present disclosure, the controller may be configured to generate a reminder in the case where the patient couples (engages) the tool to the wrong strut.

[0055] According to one aspect of the present disclosure, the controller may be configured to generate interfaces on a display of the tool, and these interfaces are structured to display corresponding operating conditions of the tool.

[0056] According to one aspect of the present disclosure, the tool may include an output shaft and a motor operable to rotate the output shaft, wherein the controller is configured to drive the motor according to prescription data.

[0057] According to one aspect of the present disclosure, the controller may be configured to monitor the rotation of the output shaft and evaluate the gearbox reduction rate between the motor of the tool and the strut.

[0058] According to one aspect of the present disclosure, the tool may further include a first coupling portion firmly attached to the output shaft and adapted to releasably engage a corresponding second coupling portion of an adjustment mechanism of the strut, so as to enable torque transmission from the motor to the adjustment mechanism, wherein the first connection portion is in electrical communication with the controller and is adapted to be electrically connected to a second connection portion when the first coupling portion engages the second coupling portion, so as to enable data transmission from the external fixed strut to the controller and vice versa.

[0059] According to one aspect of the present disclosure, the tool may further include a power source, and the electrical connection between the first connection portion and the second connection portion also enables power transmission to an external fixation strut.

[0060] The present disclosure also relates to an external fixation strut, comprising: an elongate body including at least a first shaft and a second shaft that are movable relative to each other to modify the length of the elongate body; an adjustment mechanism for moving the second shaft relative to the first shaft so as to modify the length of the elongate body; a second coupling portion of the adjustment mechanism, adapted to releasably engage with the first coupling portion of the tool as described above (according to any one of the above features, alone or in combination), so as to enable torque transmission; at least one sensor adapted to perform at least one measurement indicating the length of the elongate body; and a second connection portion of the adjustment mechanism that is in electrical communication with the first connection portion of the programmable tool when the first coupling portion engages with the second coupling portion, and is adapted to enable data transmission from the sensor to the tool.

[0061] According to one aspect of the present disclosure, the sensor may be a position sensor.

[0062] According to one aspect of the present disclosure, the second connection portion may also be adapted to receive a power signal from the tool.

[0063] The present disclosure also relates to a medical assembly, a tool as described above, and one or more external fixation struts as described above.

[0064] The features and advantages of the tool of the present disclosure will be apparent from the following description of one or more embodiments of the present disclosure with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] To more fully understand the features and advantages of the present disclosure, reference is now made to the detailed description of the present disclosure and the accompanying drawings, in which:

[0066] Figure 1 is a side view of an embodiment of an external fixation strut according to the present disclosure;

[0067] Figure 2 is Figure 1 a cross-sectional view of the external fixation strut taken along the cutting plane shown as A-A in

[0068] Figure 3 is Figure 1 a cross-sectional view of the external fixation strut taken along the cutting plane shown as B-B in

[0069] Figure 4 is a side view of an embodiment of an external fixation strut according to the present disclosure;

[0070] Figure 5 isFigure 4 Cross-sectional view of the external fixing strut taken along the cutting plane shown by C-C in

[0071] Figure 6 Perspective view of an embodiment of the external fixing strut according to the present disclosure;

[0072] Figure 7 Side view of a second embodiment of the external fixing strut according to the present disclosure;

[0073] Figure 8 Along Figure 7 Cross-sectional view of the external fixing strut taken along the cutting plane shown by D-D in

[0074] Figure 9 Along Figure 7 Cross-sectional view of the external fixing strut taken along the cutting plane shown by E-E in

[0075] Figure 10 Side view of a second embodiment of the external fixing strut according to the present disclosure;

[0076] Figure 11 Along Figure 10 Cross-sectional view of the external fixing strut taken along the cutting plane shown by F-F in

[0077] Figure 12 Perspective view of a second embodiment of the external fixing strut according to the present disclosure;

[0078] Figure 13 Is Figure 11 Enlarged detailed view of the area shown by G in

[0079] Figure 14 Is Figure 11 Enlarged detailed view of the area shown by H in

[0080] Figure 15 Top view of an embodiment of the programmable tool according to the present disclosure;

[0081] Figure 16 Side view of an embodiment of the external fixing strut beside an embodiment of the programmable tool according to the present disclosure;

[0082] Figure 17 Along Figure 16 Cross-sectional view of the external fixing strut beside the programmable tool taken along the cutting plane shown by I-I in

[0083] Figure 18 Side view of an embodiment of the external fixing strut beside an embodiment of the programmable tool according to the present disclosure;

[0084] Figure 19 is a cross-sectional view of an external fixing strut beside a programmable tool taken along the cutting plane shown by J-J in Figure 18 ; a magnified detail view of the area shown by K in

[0085] Figure 20 is Figure 19 ; a general scheme of a medical component according to the present disclosure, in which a tool interacts with an external unit and an external fixing strut;

[0086] Figure 21 a block diagram of an exemplary architecture and connection according to an embodiment of the present disclosure;

[0087] Figure 22 ; an example of an interface displayed on a display of a tool according to an embodiment of the present disclosure;

[0088] Figures 23A - 23W ; the top part of a flowchart showing the operation of a tool according to an embodiment of the present disclosure; and

[0089] Figure 24 is

[0090] Figure 25 is Figure 24 the bottom part of the flowchart of DETAILED DESCRIPTION

[0091] Although the fabrication and use of various embodiments of the present disclosure are discussed in detail below, it should be recognized that the present disclosure provides many applicable inventive concepts that can be implemented in a variety of specific contexts. The specific embodiments discussed herein merely illustrate specific ways of fabricating and using the present disclosure and do not limit the scope of the present disclosure.

[0092] Referring to the above figures, a tool for adjusting an external fixing strut according to the present disclosure is generally indicated schematically at 100, while the external fixing strut is generally indicated schematically at 200.

[0093] It should be noted that these figures represent schematic diagrams, not drawn to scale, but drawn to emphasize the important features of the invention. Moreover, different elements are depicted schematically in the figures, and their shapes vary depending on the desired application. It should also be noted that the same reference numerals in the figures represent elements having the same shape or function. Finally, the specific features described with respect to the embodiments shown in the figures are also applicable to other embodiments shown in other figures.

[0094] Obviously, as is well known to those skilled in the art, some technical details of the present invention can be replaced by other technically equivalent details without departing from the claimed scope of protection.

[0095] Moreover, when illustrating the order of processing steps, they do not necessarily follow the indicated order, and the steps may be reversed unless otherwise explicitly indicated.

[0096] The programmable tool 100 of the present disclosure is adapted to adjust the external fixed strut 200 by implementing enhanced interaction with the external fixed strut 200 and by communicating with external units such as cloud units and / or user devices, as will be disclosed below.

[0097] Figure 1 A schematic side view of an external fixed strut 200 according to the present disclosure is shown, the external fixed strut 200 including an elongated body 211 having opposite ends 215, 216 configured to be attached to respective fixing rings or fixing bows of an external fixator (preferably of the hexapod type).

[0098] The rings of the external fixator that can be fixed to the bone site via half pins or wires are themselves known and not depicted in the drawings.

[0099] The elongated body 211 is formed by a first hollow tubular shaft 212 in which a second tubular shaft 213 is slidably received. The first shaft 212 in turn consists of a hollow body 2120 (with a first end 215 at its end) and a slidable body 2121 that slides within the body 2120 and houses the second tubular shaft 213.

[0100] The relationship between the two bodies of the first shaft 212 and between the first shaft and the second shaft 213 gives the overall strut 200 a telescopic configuration, such that the length of the elongated body 201 can be adjusted as needed to maintain the interlocking rings in a predetermined relative spatial relationship.

[0101] In particular, when first adjusting the length between the two attachment points of the strut 200, the relationship defining the length of the first shaft 212 between the body 2120 and the sliding body 2121 is changed, while the relationship between the first shaft 212 and the second shaft 213 is changed to finely adjust the strut length, especially during postoperative follow-up.

[0102] The body 2120 and the sliding body 2121 are locked together by a locking screw 2122, and loosening this locking screw allows manual adjustment of the relative position of the two elements.

[0103] Conversely, the position of the second shaft 213 relative to the first shaft 212 is adjusted by a rotatable adjustment mechanism 201, which is contained in a housing 217 of the sliding body 2120 of the first shaft 212. The rotatable adjustment mechanism will be described in more detail with reference to Figure 3 be described in more detail.

[0104] The external metering cursor 219, which is firmly attached to the inner end of the second shaft 213 by legs passing through the longitudinal slit 220 in the housing 217, slides along a scale 218 integral with the housing 217 and enables visual assessment of the relative position of the second shaft 213 with respect to the first shaft 212.

[0105] To enable the user to see the scale 218, the frame of the hollow body 2120 has an open side. A cross-bridge 221 of the frame is provided at one end of the open side. The bridge 221 is visible against the background of the scale 218, enabling visual assessment of the relative position of the sliding body 2121 with respect to the body 2120, i.e., the length of the first shaft 212.

[0106] Figure 2 There is shown Figure 1 a cross-sectional view of the device.

[0107] Ball-and-socket joints 218 are provided at both ends 215, 216 of the strut 200, enabling the strut 200 to be articulated relative to the fixed ring or bow to which it is attached.

[0108] Rotation applied through the rotatable adjustment mechanism 201 defines the sliding of the second shaft 213 relative to the first shaft 212 through a threaded connection, causing the second end 216 to be drawn towards the first end 215.

[0109] Figure 3 There is shown a cross-sectional view of the above-described rotatable adjustment mechanism 201.

[0110] The rotatable adjustment mechanism 201 includes a worm gear mechanism having a worm screw 2010 meshing with a worm gear 2011, the worm gear 2011 being coaxial with and threadedly engaged with the second shaft.

[0111] The worm gear 2010 has a worm screw shaft 2010 orthogonal to the axis of the elongated body 211.

[0112] The protruding head 2013 protruding from the side wall of the housing 207 rotatably accommodates the screw shaft 2010, and as will be further discussed below, the protruding head 2013 defines a second coupling portion 203 for attaching a corresponding coupling portion of a wrench tool.

[0113] The protruding head 2013 also defines a jacket tube surrounding the second coupling portion 203. In the illustrated embodiment, the jacket tube has an inner circular profile and an outer hexagonal profile, the outer hexagonal profile including an outer groove 210 for a locking mechanism for attaching an adjustment tool.

[0114] Figure 4 There is shown a schematic side view of the external fixed strut 200 according to the present disclosure, with other elements not disclosed.

[0115] Figure 5 Shows Figure 4 Cross-sectional view of the device.

[0116] The position sensor 214 is housed within a housing 217 , is securely attached to the housing 217 , and extends along the longitudinal inner length of the first shaft 212 .

[0117] The position sensor 214 detects the absolute position of the end piece 222 of the second shaft 213 and / or the external metrological cursor 219 , returning a measured value that can be used to evaluate the relative position of the second shaft 213 with respect to the first shaft 212 .

[0118] The measurements may then be used as feedback information when adjusting the length of the external fixation strut 200 during the post-operative period, as will be disclosed in detail below.

[0119] Preferably, the position sensor 214 is a capacitive sensor, but other alternatives may be employed, such as inductive solutions. In both cases, absolute sensors are preferred over relative sensors.

[0120] Figure 6 A schematic perspective view of an external fixation strut 200 according to the invention is shown, wherein further elements are not disclosed.

[0121] Figures 7 - 12

[0013] Alternative embodiments involve external fixation struts that are shorter in size relative to the long external fixation struts previously discussed.

[0122] In such an alternative embodiment, the external fixation strut has substantially the same components and main features as the aforementioned longer embodiment. Therefore, these components and features are indicated in the figures by the reference numerals used previously and will not be described again hereinafter.

[0123] The main structural difference compared to the longer version is that here the two attachment points defined by the ball joint 218 are arranged closer to each other, because the ball joint of the first shaft 212 is not placed at its end 215, but at the opposite end of the hollow body 2120 of the first shaft 215.

[0124] Figure 13 and Figure 14 Specific details in the construction of the previously introduced position sensor 214 are shown.

[0125] The flexible signal line 2141 of the position sensor connects the input pad 2140 or board to the body of the sensor 214 , which extends near the sensing end piece 222 .

[0126] It is observed that the flexible signal line 2141 has at least one curvature to connect the housing of the rotatable adjustment mechanism to the rest of the shaft. The curvature is designed such that the radius remains above a threshold to avoid damaging the signal line during the manufacturing process.

[0127] To adjust the external fixed strut, a programmable tool 100 is used, as will be disclosed in detail below with reference to Figure 15 and subsequent content.

[0128] Figure 15 A top view of the programmable tool 100 according to the present disclosure is shown. The programmable tool 100 is in the form of a wrench, particularly an electronic wrench.

[0129] The wrench includes a rigid outer housing 111.

[0130] In the illustrated embodiment, the housing 111 is substantially cylindrical. However, the shape of the housing 111 can be any shape and size that facilitates use.

[0131] In the illustrated embodiment, the housing 111 defines a hand-held portion having a distal gripping portion 112 with an ergonomic handle, followed by a proximal interface portion 113.

[0132] The housing 111 can have various connection ports, connectors, displays, and controls.

[0133] In particular, in the depicted exemplary embodiment, the interface portion includes a first push button 114 and a second push button 115 (also referred to herein as button 1 and button 2), a display 116, and also has an indicator 120, such as a ring-shaped LED indicator (e.g., including an RGB LED), which can be lit in various colors and in a steady or pulsed mode to signal various device operating conditions to the user.

[0134] In a preferred embodiment, the ring-shaped LED indicator can have up to four lit states, respectively signaling: requesting user action, wrench operation in progress, successful or failed completion of wrench operation. In an embodiment, there are also other states of the LED indicator, such other states indicating, for example, a charging operation.

[0135] The device can also include a buzzer or any other audio device. Moreover, the device can also include a wireless charging component, as well as a near-field communication (NFC) component for communicating with other electronic devices, as will be described in detail below.

[0136] The device further includes a front muzzle 107 located in front of the interface portion 113, which is arranged to be connected to the torque input port of the rotatable adjustment mechanism 201 of the external fixed strut 200.

[0137] Figure 16 Shows a side view of the programmable tool 100 about to be coupled to the external fixing strut 200.

[0138] Figure 17 is Figure 16 A cross-sectional view of two devices, and schematically shows the main components inside the housing 111 of the programmable tool 100.

[0139] The programmable tool 100 includes a power source 106 in the form of a rechargeable battery; an electric motor 102, which preferably includes a gearbox coaxial with the coaxial output shaft 101; and a controller 104 in the form of a PCB, for example. The controller 104 is adapted to manage the operation of the tool 100 and is not limited by a specific configuration.

[0140] The programmable tool 100 may also include an internal memory, which can be conveniently used to store the patient's prescription and the actual lengths of the plurality of struts constituting the external fixator to be adjusted by the tool 100. In any case, the present disclosure is not limited by the architecture of the tool memory, which may be an integral part of the controller 104 or may also be a separate memory part operably connected to the controller 104.

[0141] The programmable tool 100 also includes means (referred to herein as "TX") for transmitting data to an external unit (particularly to an external data source), such as in the form of a data port and / or a wireless connection. Preferably, the programmable tool has a SIM housing (not shown), which is used to provide an Internet connection for the device, and even any other suitable means can be used for this purpose. Such means TX may also include, for example, a Bluetooth connection port or a Wi-Fi connection port for connecting to a user device or other external devices, as well as the above-mentioned NFC means.

[0142] In some embodiments, means for wireless charging may be provided.

[0143] The controller 104 of the programmable tool 100 is adapted to communicate with an external unit (particularly a cloud unit) directly or via a portable electronic user device (such as a smart phone) to retrieve the surgeon's prescription and update the status including at least the lengths of several external fixing struts 200 of the external fixator, as will be referred to below Figures 21 to 25 Disclosed.

[0144] The controller 104 is connected to the push buttons 114, 115, the display 116, and the annular LED indicator to read the user's commands, transmit status updates, or guide the user throughout the process of adjusting all the struts 200 according to a given prescription.

[0145] The muzzle 107 of the programmable tool 100 houses the output shaft 101, and the end of the output shaft 101 is a first coupling portion 103 in the form of a wrench socket (in particular, a hexagon socket).

[0146] The muzzle further includes a locking mechanism 109 that is operable to fix and selectively release the engagement of the first coupling portion 103 with the second coupling portion 203. When the locking mechanism 109 is engaged, the protruding head 2013 of the rotatable adjustment mechanism 201 is received within the annular groove 108 of the muzzle 107, as Figure 20 best seen in.

[0147] The locking mechanism 109 is defined by the body of the muzzle 107, which can be retracted into the programmable tool 100, and the housing 111 presses it against an elastic member, which can be in the form of a spring 1090, as Figure 20 best seen in. Inside the muzzle 107, there is a latch element 110, which can be in the form of a roller that moves along an inclined path, and the roller is biased from the outside under the action of the spring 1090 so as to engage.

[0148] In addition, the tool 100 includes a first connection portion 105 (for example, arranged around the first coupling portion 103), which is used to be electrically connected to the second connection portion 205 of the support column 200.

[0149] When the locking mechanism 109 is engaged, the first connection portion 105 is connected to the second connection portion 205 of the support column 200 and provides a data connection, which allows the controller 104 to retrieve data from the sensor 214.

[0150] The electrical connection further ensures power supply from the power source 106 to the sensor 214.

[0151] Figure 18 A side view of the programmable tool 100 about to be coupled to the external fixed support column 200 is shown.

[0152] Figure 19 is Figure 18 a cross-sectional view of two devices.

[0153] Figure 20 is Figure 19 an enlarged view of, which shows details of the first connection portion 105 according to an exemplary embodiment of the present disclosure.

[0154] The first connection portion 105 includes a plurality of inner connectors 1050 located at the bottom of the annular groove 108, which are preferably in the form of pogo-pins and are used to connect the first electrodes.

[0155] In addition, the first connection portion 105 includes a plurality of outer connectors 1051 protruding from the outer surface of the annular groove 108, preferably in the form of clips or leaf spring connectors. The outer connectors 1051 are used to connect the second electrode.

[0156] In use, the inner connector 1050 contacts the inner surface 2050 of the outer tube of the protruding head 2013, while the outer connector 1051 contacts the outer surface 2051 of the same outer tube. As Figure 9 best seen, the inner surface 2050 and the outer surface 2051 are separated by a dielectric layer 2052.

[0157] To improve the interaction between the tool 100 and the external fixing strut 200, advantageously, according to the present disclosure, the controller 104 includes a set of instructions that, when executed, cause the tool 100 to automatically perform the operations disclosed below.

[0158] Figure 21 is a general schematic diagram of a medical component 1000, which includes a tool 100 and an external fixing strut 200 having the above-described rotatable adjustment mechanism 201 for length adjustment. As previously seen, the external fixing strut 200 includes a second connection portion 205 for data communication with the tool 100. On the other hand, the tool 100 includes a first connection portion 105 that is adapted to perform data communication with the external fixing strut 200 via the second connection portion 205.

[0159] Therefore, as previously described, the first connection portion 105 and the second connection portion 205 also enable data transmission between the external fixing strut 200 and the controller 104 of the tool 100, for example, from the sensor of the external fixing strut 200 to the controller 104.

[0160] In operation, first, the controller 104 is configured to allow the tool 100 to be associated with the situation of a specific patient. For example, the controller 104 can load information related to the patient into the memory of the tool 100 and call the information when needed (e.g., at the start of the association phase, when the tool 100 is turned on). The surgeon (or any other suitable operator) can then confirm the performed association and enter the next operation step, for example, by pressing one of the push buttons of the tool 100 (e.g., button 1). Thus, the surgeon performs and confirms this first association, thereby setting up the tool for use with the next patient.

[0161] Suitably, once associated with a specific patient, the controller 104 is configured to download prescription data related to the patient (referred to herein as "DATA") from the above-described external unit (identified herein by the reference numeral 300), such as a cloud unit. In some embodiments, the download can occur automatically.

[0162] The external unit 300 can be, for example, a web server that the tool 100 accesses directly or indirectly through its component TX.

[0163] For example, the tool 100 can be connected via the component TX to a user device 310 (such as a smart phone) equipped with a suitable application or capable of accessing a dedicated internet portal to establish a connection with the external unit 300 and download the prescription data DATA into the tool 100, in particular into its memory.

[0164] Thus, the download of the data can occur directly via the tool 100 itself or can occur indirectly via the user device, and this also applies to updates to be downloaded subsequently.

[0165] The prescription data DATA is related to the patient situation associated with the tool 100 and includes information and instructions for adjusting the external fixation strut 200 of the patient, such as, for example, a set of dates and / or times at which the adjustment is to be applied to the external fixation strut 200, and, for example, the extent of the adjustment in terms of the strut length for each adjustment step.

[0166] It is observed that each prescription has an expiration date. If the prescription is not downloaded within that date, then the prescription becomes invalid and no other treatment is allowed.

[0167] Once the download is complete, the surgeon (or any other suitable operator) can confirm by pressing one of the pressing buttons of the tool 100 (e.g., button 1). Thus, in the standard setup operation, the surgeon confirms the successful download of the prescription data DATA, as discussed above. As will be discussed below, in the case of a prescription update, the patient can receive the update (e.g., via a mobile application), and then he / she can confirm the download of the updated prescription, and then can confirm its successful download.

[0168] Once the surgeon (or any other suitable operator) has completed the above preliminary operations (i.e., preliminary association and prescription download), the controller 104 then puts the tool 100 into a waiting state, for example, after further pressing one of the pressing buttons, in which it waits for a preliminary coupling with the patient's external fixation strut 200, in particular for transmitting data therewith via the first connection part 105.

[0169] Also in this case, this preliminary coupling is performed by the surgeon (or any other suitable operator); in particular, after connecting the tool 100 to the external fixation strut 200 in the preliminary coupling operation, the controller 104 is able to automatically identify the coupling state of the tool 100 with the external fixation strut 200 and signal this coupling state.

[0170] Then, based on this coupling, the controller 104 communicates with the external fixed strut 200 via the first connection part 105 and the second connection part 205. In particular, it performs data communication.

[0171] In particular, in this initial coupling, the controller 104 is capable of writing an ID to the strut memory in order to assign a unique identity to a brand-new strut or re-code a strut with an incorrect code. In other words, during the said initial coupling, the controller 104 is configured to assign a strut ID to the external fixed strut 200 for its identification.

[0172] In this coupling, other initial information can also be exchanged with the strut (for example, if an ID has already been assigned, then reading the said ID, and reading the length of the strut, as will be described in detail below).

[0173] Then, after being coupled to and exchanging initial information with the external fixed strut 200 (i.e., after the above-mentioned initial coupling), the tool 100 (i.e., its controller 104) enters an idle state (for example, after pressing the push button again after the coupling is completed), in which it waits for a specified time / date for strut adjustment to be applied.

[0174] In this idle state, the patient can also check the next adjustment date / time, for example, by pressing the push button of the tool 100.

[0175] When the date and / or time for strut adjustment arrives, the tool 100 can generate a reminder (which can be a visual and / or audible reminder), and the patient can press the push button (such as button 1) of the said tool 100; the controller 104 is then configured to cause the tool 100 to enter a further waiting state, in which it waits for a sequential mechanical coupling with the external fixed strut 200 in order to apply a specified adjustment thereto. This sequential coupling operation involves a mechanical engagement between the tool 100 and the tool 200, and this is typically performed by the patient.

[0176] The controller 104 is configured to wake up the tool 100 when a treatment is approaching. In an embodiment, the wake-up of the tool 100 is performed by using an internal RTC.

[0177] In an embodiment, when a treatment is approaching, the controller 104 is also programmed to estimate the power budget for completing the entire treatment.

[0178] Then, when the patient mechanically engages the tool 100 with the external fixation strut 200, the controller 104 is configured to automatically apply a prescribed adjustment by driving a dedicated member of the tool 100 that acts on the rotatable adjustment mechanism 201 of the external fixation strut 200. More particularly, the controller 104 is configured to drive the motor 102 of the tool 100 in accordance with the prescription data DATA so as to apply the correct adjustment to the strut 200. As will be discussed below, the length of the external fixation strut 200 can be used to control the drive member of the tool 100.

[0179] When the tool 100 is engaged with the external fixation strut for correction, the patient is notified when the tool successfully adjusts the strut progressive length, and by re-pressing the push button (e.g., button 1), the tool can return to the idle state again.

[0180] Typically, the fixation device includes a plurality of struts, such as six struts. Thus, after completing the coupling with one external fixation strut, the controller 104 is configured to check whether the tool 100 is to be engaged with other external fixation struts, and if so, then put the tool 100 into a waiting state (e.g., after pressing the push button), where it waits for coupling with the other external fixation struts. This applies both to the initial coupling performed by the surgeon and to the mechanical engagement performed by the patient, where the patient is precisely guided and errors due to previous pairing and error message generation are avoided.

[0181] Thus, in an embodiment, after the surgeon performs the initial pairing between the tool 100 and the strut 200, the tool 100 exactly knows the identity of each strut 200 of the external fixation device (e.g., which is the correct strut 1, strut 2, etc.). In this way, if the patient engages the wrong strut, then the tool 100 is adapted to return this feedback to the user and thus generate a warning in the form of an error message, such that the patient knows that he / she is engaging the wrong strut.

[0182] When the patient engages the strut 200 with the tool 100, the tool 100 retrieves useful information (referred to herein as "INFO") from the external fixation strut 200, such as its length.

[0183] In an embodiment, the actual length of the external fixation strut 200 is obtained by the controller 104 by reading data from the position sensor 214 of the external fixation strut 200.

[0184] Thus, the information INFO (exchanged during successive couplings performed by the patient) can be related to the measurement of the length of the external fixation strut 200, and when the tool 100 is coupled to the external fixation strut 200, the controller 104 is configured to retrieve at least said length from the position sensor 2014 of said external fixation strut 200. This value can then be used for successive adjustment steps in order to perform feedback control when driving the tool 100 according to the prescription data DATA.

[0185] In addition, other information can be part of the information INFO, such as the strut ID for identifying the external fixation strut 200, or any other useful information, which is exchanged.

[0186] As previously mentioned, the tool 100 is configured to generate a reminder when a prescribed adjustment date and / or time is reached, such that the patient can couple the tool 100 to the strut 200 in a timely manner when needed. However, the user can also postpone the application of the adjustment to the external fixation strut 200, for example, by pressing one of the pressing buttons of the tool 100 when the reminder is generated; in an embodiment, by pressing the pressing button 1, the tool enters a waiting state, in which it waits to be coupled to the strut, while by pressing the button 2, the correction is postponed.

[0187] More particularly, in an embodiment, when a correction is to be applied and a reminder is generated, the controller 104 is programmed such that the patient has the following options:

[0188] - Execute the entire correction immediately;

[0189] - Execute a partial correction immediately;

[0190] - Pause the reminder on the tool and postpone the correction, without performing any correction until the next adjustment is applied;

[0191] - Pause the reminder on the tool and postpone the correction, where the correction is applied at any time between the postponed operation and the next adjustment to be applied.

[0192] In the case where the correction is postponed and the user does not perform an action before the next correction, the postponed correction will be automatically executed during the next correction; in this case, the postponed correction will be added to the standard correction to be applied in the next correction step. In an embodiment, when postponing (or when performing a partial correction), the amount of correction added in the next correction step is based on the time elapsed since the last correction was applied.

[0193] In addition, as described above, according to an embodiment of the present disclosure, the controller 104 is configured to detect an update of the prescription data DATA from the external unit 300 and download the update either directly in its memory or indirectly via the user device 310 in order to replace the previously downloaded prescription data with the updated prescription data so that the correct prescription can always be applied.

[0194] Therefore, it is clear that the automated operation of the tool 100 avoids patient errors and improves the overall postoperative adjustment process, and the patient is correctly guided through all steps of the operation of the tool 100.

[0195] Figure 22 is a block diagram of an exemplary architecture and connection according to an embodiment of the present disclosure, in which only the data connections are shown for clarity.

[0196] In the example shown, the controller 104 of the tool 100 includes a main board 600, which integrates the correct software modules for implementing the functions of the tool 100 disclosed above.

[0197] The communication module 601 is configured to establish a communication protocol with the strut 200. The communication between the tool 100 and the strut 200 can be carried out through a DC-coupled bus, through which both power and data are transmitted. In an embodiment, the communication is performed through a half-duplex serial bus, in which data is written to and read from the strut 200.

[0198] The communication module 601 performs two main functions, namely writing an identification code to assign an identity ID to a brand-new strut or recoding a mis-coded strut (and this operation is performed by a surgeon or any other suitable operator, as shown above), and reading the strut ID (which is performed in both surgeon and patient modes to read its ID after coupling the strut to the tool).

[0199] The communication module 601 is also configured to allow reading of the strut length and position via the strut sensor.

[0200] The controller 104 is also programmed to implement a power management module 602, which is configured to manage all power paths of the tool 100.

[0201] The controller 104 is also programmed to implement a USB data connection module 603 and a motor management / encoder module 604.

[0202] More particularly, the motor management / encoder module 604 is configured to ensure correct operation of the motor, which can be a brushed motor. The hardware for driving the motor is capable of detecting motor faults / overloads, setting the speed, and using a closed-loop PID to verify that the target speed is reached. In particular, motor acceleration and deceleration ramps are implemented and controlled by the closed-loop PID by reading the feedback Hall sensors.

[0203] In addition, the buzzer / LED ring module 605 is implemented as part of the safety module, which is configured to inform the operator / patient in case of an error, warning, or notification, as shown above. The sound signal can have a predefined pattern that can vary based on the situation, and the sound signal is associated with the corresponding LED color. The LED ring 120 is driven by a serial cascade bus (shift register) that is capable of sending color and intensity information to the LEDs. This operation is continuously performed to ensure the correct color is always displayed according to the active alerts in the system.

[0204] The software module then includes a keyboard management module 606, which is configured to discern the pressure of the push buttons of the tool 100 and trigger the correct actions.

[0205] The software module then includes an external flash and Ram module 607 and a display module 608.

[0206] Moreover, the connection module 609 is configured to enable connection to an external device 300, for example to check for new firmware updates, check for new prescriptions, upload the latest life counters, logs, or any data that must be loaded to the cloud, receive commands to enable some specific operation modes of the tool 100 (e.g., service mode or surgeon mode), etc.

[0207] Finally, the safety module 610 is configured to ensure the correct and safe operation of the tool.

[0208] As part of the safety module, during treatment, the prescribed extension is monitored both by reading the data of the sensors of the strut and by the rotation of the motor shaft. Correct mathematical calculations are applied taking into account the gearbox reduction ratio between the motor and the strut of the tool 100. If the values do not match within a certain threshold, then the controller is configured to enter the tool 100 in a safe mode. In other words, the controller is configured to monitor the rotation of the output shaft 101 and evaluate the gearbox reduction ratio between the motor 102 and the strut 200 of the tool 100.

[0209] The controller 104 can also be configured to generate interfaces I1 - I23 on the display 116 of the tool 100, which are structured to display the corresponding operating conditions of the tool 100.

[0210] Figures 23A to 23W An example of an interface displayed on a display of a tool according to an embodiment of the present disclosure is shown. These figures will be discussed in conjunction with Figure 24 and Figure 25 below.

[0211] Figure 24 and Figure 25 show the top and bottom portions of a flowchart of the operation of the tool 100 as described above in conjunction with Figure 21 .

[0212] In summary, the user can, for example, turn the device from the off state 500 to the on state 501 at a given time by pressing button 1 or button 2. This can correspond to a transition from the Figure 23A interface I1 to the Figure 23B interface I2.

[0213] A similar user action may be required to return the device to the off state 500.

[0214] After being turned on for a given time, the device will be associated with a specific situation 502, as represented by the interfaces I3, I4, and I5 of Figure 23C , 23D and 23E.

[0215] Then, after the user issues a command, the device connects to the Internet, retrieves prescription data DATA of the patient's situation 503 from a dedicated portal, and informs the patient when the prescription treatment is successfully transmitted to the tool memory. This is represented by the interfaces I6, I7, and I8 of Figure 23F , 23G and 23H.

[0216] As previously mentioned, there are various ways (e.g., GSM, BT, NFC, WiFi) to directly - indirectly connect to the external unit 300, and the present disclosure is not limited by the communication means employed.

[0217] After the prescription is uploaded to the internal memory, the device is in a general waiting state 504, which can be signaled to the user via the display 116 and / or the ring - shaped LED indicator, as shown in the interface I9 of Figure 23I .

[0218] According to a user command, for example, pressing button 1, the device enters a coupling waiting state 505 and will signal via the display 116 that it is ready to connect to a given support, as shown in the interface I10 of Figure 23J .

[0219] In the coupling waiting state 505, it is expected that the user will mechanically couple the device to the support 200, as discussed previously, which will also result in a data connection. When the tool is being coupled to the support, the tool passes through Figure 23KThe interface I11 is indicated; and when the coupling is completed, the tool indicates through Figure 23L the interface I12.

[0220] When the data connection is executed 507, the device advises the user that other struts 200 can be coupled in a similar manner.

[0221] Once all the struts 200 are correctly coupled, the device enters the coupling state 508, as Figure 23M represented in the interface I13.

[0222] Then, according to the user's command, the device enters the idle state 509 ( Figure 23N the interface I14), ready to signal when the specified calibration date and / or time 510 is reached. In this state, the user can query the device (e.g., by pressing button 1), and the device will then display the next calibration time 511 ( Figure 23O in the interface I15).

[0223] Then, when the calibration time 510 is finally reached, the user can be notified via an audio and / or visual signal that he / she needs to take action (as Figure 23P represented in the interface I16).

[0224] Then, the user will be given the option to perform or postpone the strut adjustment 512. Button 1 and button 2 can be used alternately to distinguish between these two options.

[0225] If the user decides to perform the calibration, then the device will guide the user to engage the strut 200 to be adjusted 513 ( Figure 23Q the interface I17). Once the external fixed strut 200 is engaged, the device will automatically perform the adjustment in the adjustment step 514, and then signal the user that the adjustment is completed 515 ( Figure 23R and 23S the interfaces I18 and I19).

[0226] If another strut is to be adjusted, then steps 513 - 515 are repeated; otherwise, the device signals the user that the calibration is completed 516 ( Figure 23T the interface I20), and returns to the idle state 509.

[0227] Starting from the idle state 509, the device is also able to update the prescription 517 when a prescription update is detected (see Figure 23U , 23V and the interfaces I21, I22 and I23 of 23W). This update can be activated by the patient pressing a push button when the tool is in the idle state, or can be automatically completed by the tool 100 through periodic check for updates (e.g., by interacting with the external unit 300).

[0228] In an embodiment, the patient or the surgeon may engage the tool 100 to a particular strut 200 at any time (except during the correction phase) to obtain its length (state 518), and by pressing one or more buttons, the controller 104 is configured to start testing the strut 200 to verify that the mechanical part and the firmware of the strut work as expected (state 520).

[0229] Moreover, in an embodiment, during the strut adjustment operation, the patient may disengage the tool 100 from the strut 200 as a safety mechanism in case he / she feels pain during the treatment (state 522).

[0230] It will be understood that the specific embodiments described herein are shown by way of illustration only and are not a limitation of the present disclosure. The main features of the present disclosure may be employed in various embodiments without departing from the scope of the present disclosure. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific devices and processes described herein. Such equivalents are considered to be within the scope of the present disclosure and are covered by the claims.

[0231] All publications and patent applications mentioned in this specification indicate the level of skill of those skilled in the art to which the present disclosure pertains. All publications and patent applications are hereby incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0232] In the claims and / or the specification, when the word "a" or "an" is used in conjunction with the term "comprising", it may mean "one", but is also consistent with the meaning of "one or more", "at least one", and "one or more than one". The term "or" as used in the claims is used to mean "and / or", unless expressly indicated to refer only to alternatives or that the alternatives are mutually exclusive, but the present disclosure supports both the definition of only alternatives and "and / or".

[0233] As used in this specification and the claims (s), the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include") or "containing" (and any form of containing, such as "contains" and "contain") are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.

[0234] Obviously, those skilled in the art can make various modifications and changes to the above tools to meet accidental and specific needs, and all of these are within the scope of the present disclosure as defined by the appended claims.

Claims

1. A tool (100) for adjusting an external fixation strut (200), the external fixation strut (200) having an adjustment mechanism (201) for length adjustment and a second connection part (205), the tool (100) comprising: - A first connection part (105) adapted to perform data communication with the external fixation strut (200) via the second connection part (205); And - A controller (104), the controller (104) including command instructions and, based on the command instructions, being configured to: - Download prescription data (Data) from an external unit (300), the prescription data (Data) being related to the condition of a determined patient and including instructions for performing an adjustment on the patient's external fixation strut (200); - Enter a waiting state, wherein the controller waits to be coupled to the patient's external fixation strut (200) in order to transfer data therewith via the first connection part (105); - After the tool (100) is coupled to the external fixation strut (200), discern the coupling state with the external fixation strut (200); - Based on the coupling state, communicate with the external fixation strut (200) via the first connection part (105); And - Once the coupling is complete and data has been exchanged with the external fixation strut (200), wait for the date and / or time at which a prescribed adjustment is to be applied based on the prescription data (DATA).

2. The tool (100) according to claim 1, wherein, During the coupling, the controller (104) is configured to assign a strut ID to the external fixation strut (200).

3. The tool (100) according to claim 1 or 2, wherein the prescription data (DATA) includes a set of dates and / or times for successive adjustments to be applied to the external fixation strut (200) and the extent of the adjustments, and wherein the controller (104) is configured to generate a reminder when the date and / or time for the prescribed adjustment arrives.

4. The tool (100) according to any one of the preceding claims, wherein the state in which the controller (104) waits for the date and / or time at which a prescribed adjustment is to be applied is an idle state.

5. The tool (100) according to any one of the preceding claims, wherein, When the date and / or time for applying the strut adjustment arrives, the controller (104) is configured to enter a further waiting state, wherein the controller waits for successive coupling in order to apply the prescribed adjustment to the external fixation strut (200), the successive coupling involving mechanical engagement with the external fixation strut (200).

6. The tool (100) according to claim 5, wherein, After mechanical engagement with the external fixation strut (200) in the further waiting state, the controller (104) is configured to apply the prescribed adjustment by driving a tool member adapted to act on the adjustment mechanism (201) of the external fixation strut (200).

7. The tool (100) according to claim 5 or 6, wherein, During the successive coupling, the controller (104) is configured to retrieve information (INFO) related to the external fixation strut (200) from the external fixation strut (200), wherein the information (INFO) at least includes a measurement indicating the length of the external fixation strut (200), the length being used to drive feedback control of the tool (100) according to the prescription data (DATA).

8. The tool (100) according to claim 7, wherein the controller (104) is configured to retrieve a measurement indicating the length of the external fixing strut (200) from a sensor (214) of the external fixing strut (200), the data passing through the first connection part (105).

9. The tool (100) according to any one of the preceding claims, wherein the controller (104) is configured to detect an update of prescription data (DATA) from an external unit (300) and download the update so as to replace the previously downloaded prescription data with the updated prescription data.

10. The tool (100) according to any one of the preceding claims, wherein the controller (104) is configured to postpone applying an adjustment to the external fixing strut (200) after a user's selection.

11. The tool (100) according to claim 10, wherein, In the case where the user selects to postpone, the controller (104) is configured to apply the adjustment that has been postponed to the strut (200) during the next adjustment operation, and the amount of adjustment added during the next adjustment operation is based on the time elapsed since the last performed adjustment operation.

12. The tool (100) according to any one of the preceding claims, comprising push buttons (button 1, button 2) adapted to be engaged by a user to initiate or complete or select an operating step of the tool (100), and comprising a member (TX) for transmitting data to and from an external unit (300).

13. The tool (100) according to any one of the preceding claims, wherein, After completion of coupling with one external fixing strut, the controller (104) is configured to check whether the tool (100) is to be coupled to other external fixing struts, and if so, then enter a waiting state, wherein the controller (104) waits for coupling with the other external fixing struts.

14. The tool (100) according to claim 13, wherein the controller (104) is configured to generate a reminder in the case where the patient engages the tool (100) with the wrong strut.

15. The tool (100) according to any one of the preceding claims, wherein the controller (104) is configured to generate an interface (I1 - I23) on a display (116) of the tool (100), the interface (I1 - I23) being structured to display the corresponding operating status of the tool (100).

16. The tool (100) according to any one of the preceding claims, comprising: - an output shaft (101); and - a motor (102) operable to rotate the output shaft (101), wherein the controller (104) is configured to drive the motor (102) according to prescription data (DATA).

17. The tool (100) according to claim 16, wherein the controller (104) is configured to monitor the rotation of the output shaft (101) and evaluate the gearbox reduction rate between the motor (102) of the tool (100) and the strut (200).

18. The tool (100) according to claim 16 or 17 further comprises a first coupling part (103) which is firmly attached to the output shaft (101) and is adapted to releasably engage with a corresponding second coupling part (203) of the adjustment mechanism (201), so as to enable torque transmission from the motor (102) to the adjustment mechanism (201) of the support column (200), wherein the first connection part (105) is in electrical communication with the controller (104) and is adapted to be electrically connected to the second connection part (205) when the first coupling part (103) engages with the second coupling part (203), so as to enable data transmission from the externally fixed support column (200) to the controller (105) and vice versa.

19. The tool (100) according to claim 18, wherein the tool (100) further comprises a power source, and wherein the electrical connection between the first connection part (105) and the second connection part (205) also enables power transmission to the externally fixed support column (200).

20. An externally fixed support column (200) comprising: - a slender body (211) including at least a first shaft (212) and a second shaft (213) which are movable relative to each other to modify the length of the slender body (211); - an adjustment mechanism (201) for moving the second shaft (213) relative to the first shaft (212) so as to modify the length of the slender body (211); - a second coupling part (203) of the adjustment mechanism (201) which is adapted to releasably engage with the first coupling part (103) of the tool (100) according to any one of the preceding claims to enable torque transmission; - at least one sensor (214) which is adapted to at least perform a measurement indicating the length of the slender body (211); and - a second connection part (205) of the adjustment mechanism (201) which is in electrical communication with the first connection part (105) of the tool (100) when the first coupling part (103) engages with the second coupling part (203), and the second connection part (205) is adapted to enable data transmission from the sensor (214) to the tool (100).

21. The externally fixed support column (200) according to claim 20, wherein the sensor (214) is a position sensor.

22. The externally fixed support column (200) according to claim 20 or 21, wherein the second connection part (205) is also adapted to receive a power signal from the tool (100).

23. A medical assembly (1000) comprising: - the tool (100) according to any one of claims 1 to 19; and - one or more externally fixed support columns (200) according to any one of claims 20 to 22.

Images