Improved programmable tool for adjusting external fixation posts

Abstract

The present disclosure relates to a tool for adjusting an external fixator post, the external fixator post having an adjustment mechanism for length adjustment and a second connection part, the tool comprising a first connection part configured to perform data communication with the external fixator post via the second connection part, and a controller including command instructions. Based on the command instructions, the controller is configured to download prescription data related to a determined patient case from an external unit and including instructions for performing the adjustment of the patient's external fixator post, enter a waiting state awaiting coupling with the patient's external fixator post to communicate data therewith via the first connection part, recognize the coupling status with the external fixator post after the tool is coupled to the external fixator post, communicate with the external fixator post via the first connection part based on the coupling, and wait for a date and / or time for the prescribed adjustment to be performed based on the prescription data once coupling is complete and data has been exchanged with the external fixator post. Related external fixator posts 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 tools used for incremental or decremental adjustment of the struts of an external fixator, especially during the post-operative period. The following description refers to this technical field solely for the purpose of simplifying the description. [Background technology]

[0002] Without limiting the scope of the present disclosure, its background is described herein with respect to external fixation devices and associated tools for adjustment of their struts or other connecting rods.

[0003] Generally, external fixation devices are commonly used in a variety of surgical procedures, including limb fracture fixation, bone distraction, and deformity correction. This process involves the application of a rigid framework that is placed externally around the limb and comprises several rings or arches that are attached to the bone compartments using wires and half pins that are inserted into the bone compartments and connected to the relevant parts of the external rigid framework.

[0004] Multiple rings of a rigid framework positioned opposite one another are interconnected by either threaded and / or telescoping posts, either directly or in conjunction with single- or multi-planar hinges, which allow the position of the rings relative to one another to be adjusted longitudinally, rotationally, horizontally, or angularly over a period of time.

[0005] For example, in limb lengthening surgery, a bone is surgically divided into two compartments, and wires and half pins are inserted into the bone compartments above and below the surgical bone incision and attached to rings of a rigid framework interconnected by struts or telescoping connecting struts.

[0006] For limb lengthening, the opposing rings are preferably directly interconnected by at least three or four threaded or telescoping struts that allow periodic length adjustment and gradual longitudinal separation of the bone segments.

[0007] A rigid framework is used to gradually separate the two bone compartments longitudinally over a period of time (e.g., 1 mm per day). This allows new bone to gradually form in the gap between the bone compartments created by this traction technique. Once the desired amount of distraction is achieved (e.g., 5-6 cm), an external device is secured in place and placed over the bone compartments 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 distraction).

[0008] Similarly, in deformity correction, a bone is surgically divided into two compartments (usually at the apex of the deformity), and wires and half pins are inserted into the bone compartments above and below the surgical bone incision and attached to rings of a rigid framework. Again, the rings on opposite sides of the rigid framework are interconnected by threaded posts with attachment hinges and angular distractors used to gradually angularly spread the two bone compartments over a period of time.

[0009] One common fixation device is a circular metal structure known as an Ilizarov appliance. Used for limb lengthening and deformity correction, the Ilizarov appliance consists of multiple rings or arches attached to the outside of the limb and secured to surgically separated bone segments using wires and half pins. For angular deformity correction, the opposing rings of the Ilizarov appliance are connected by a pair of hinges that act as the axis of rotation for the bone segments and an angular distractor that gradually spreads the two rings and associated bone segments apart.

[0010] Another common external fixator is known as the Taylor Spatial Frame, which is a hexapod external fixator 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 attached to each bone segment with wires and half pins, connected by five or six telescoping struts. Each strut has a multi-plane hinge at each end. Each strut can be telescopic as needed, allowing the two interconnected ring segments to be pulled toward or pushed away from each other.

[0012] Other examples of this type of external fixation device are commercially known as TrueLok and Sheffield.

[0013] By adjusting the length of the struts, it is possible to rapidly or gradually manipulate each segment of the bone in multiple axes to simultaneously lengthen the limb and correct angular, translational, and rotational deformities.

[0014] Routine strut length adjustments are typically calculated by dedicated software. Once the device is attached to the bone segments, numerous parameters, including deformation parameters, frame parameters, and attachment parameters, are entered into the software to characterize the relative position of one ring relative to another and the relative positions of the bone segments relative to each other and to the rings. After calculating the total amount of each strut length adjustment, the software provides tabular instructions ("prescriptions") for the strut length adjustment to be achieved for each increment, including the identification number of the single strut, the amount of adjustment required, and the time over which these and the adjustments are scheduled to occur. In most cases of deformity correction, the struts are adjusted by different amounts in different directions (shortening / lengthening).

[0015] Because this prescription requires multiple adjustments over time, typically up to four times a day, these adjustments often cannot be performed by a surgeon or specialist, so the task of following the prescription by turning an adjustment knob on a post or a nut on a threaded rod with a wrench falls to the patient or their relatives.

[0016] Such strut length adjustments are time consuming (e.g., by loosening and retightening threaded rod nuts before and after adjustment), do not allow precise length adjustments (e.g., minute adjustments are difficult to monitor), and contribute to overall frame instability during adjustments (e.g., due to dimensional clearances between connecting elements).

[0017] Furthermore, length adjustment prescriptions can be complex and prone to human error during the complex prescription process. Although patients are asked to verify that the frame is in accordance with the prescription by checking the strut length, it is entirely possible that an error will go unnoticed due to careless checking or no checking at all.

[0018] Additionally, it must be considered that feedback to the surgeon is dependent on the patient, who is required to communicate strut adjustments, usually by uploading information to a dedicated portal. Again, the patient may inadvertently provide the surgeon with inaccurate or incomplete information.

[0019] It is readily apparent that errors in implementing the prescription, especially if not immediately identified by the surgeon, can adversely affect the final outcome of the correction process.

[0020] To alleviate the above-mentioned drawbacks, programmable tools for incrementally adjusting the length of the struts of an external fixator have recently been proposed. For example, prior art document WO 2009 / 105479, filed in the name of Texas Scottish Rite Hospital for Children, describes such a tool as a powered wrench for engaging the adjustment mechanism of the struts of the external fixator. The tool has an internal memory for storing prescription adjustment parameters and is configured to automatically adjust each strut according to those parameters.

[0021] Although the above programmable tools offer numerous advantages over the prior art discussed above, drawbacks remain, particularly with regard to the ease of use of the devices.

[0022] Indeed, it is recommended to input real-time measurements of the strut length into the tool in order to correctly adjust the strut length parameters according to the stored prescription. If the tool performed length increases or decreases according to the prescription without feedback, the adjustment process could easily become flawed due to incremental errors, and incorrect manipulation by the patient (e.g., coupling the tool to the wrong strut when applying the prescription) could prevent the correct execution of the adjustment plan over time.

[0023] Therefore, the programmable tool is preferably provided with a means for measuring the length of the strut, such as a digital ruler coupled to each end of the strut. However, such a measuring means adds to the complexity of the device and, more importantly, requires active manipulation by the patient, making the process of applying the prescription more difficult and prone to human error.

[0024] It has been determined that alternative methods for measuring the length of the pole, such as through a sensor built into the pole itself, have not previously been considered due to the difficulty of powering the internal sensor and transmitting the sensor signal to the tool. In particular, wireless methods would be difficult to implement due to practical design concerns and regulatory compliance, while the addition of a wired plug would be impractical from both a product design and usability perspective.

[0025] Furthermore, the programmable tool preferably requires additional interface means, such as a means for identifying individual struts, to allow the patient to correctly administer the prescription. This could be, for example, an RFID reader that reads the unique identification code from the strut. However, this adds complexity and introduces a degree of uncertainty into the process, as the patient may mistakenly skip the step of identifying the strut, or, after correctly identifying the strut, mistakenly administer the prescribed length increase or decrease to a neighboring strut.

[0026] Thus, with conventional solutions, the interaction between the adjustment tool, the post to be adjusted, and the patient is cumbersome and can lead to operational errors. It is therefore desirable to provide a system for adjusting an external fixation post that overcomes or at least mitigates the shortcomings identified with the prior art.

[0027] The technical problem underlying the present invention is to provide a tool for adjusting an external fixator post, with functional and structural features that make it possible to overcome the limitations and drawbacks of the solutions of the prior art, in particular a tool with improved interaction with the external fixator post(s), allowing at the same time efficient operation of the external fixator post and automation / ensuring of the adjustment process, while avoiding adjustment errors, without burdening the user with additional tasks such as identifying the post number or externally measuring the post length, and without relying on wireless data communication between the adjustment tool and the post. Summary of the Invention

[0028] The solution idea underlying the present disclosure is the idea of ​​providing a programmable tool configured to couple with one or more posts of an external fixation device, which is able to exchange operational data with the post (and supply power to the post), e.g., the programmable tool being able to receive data from sensors (e.g., position sensors) of the post and use said data by an integrated controller that automatically drives the programmable tool for adjustment of the external fixation post.

[0029] More specifically, the tool of the present disclosure has an innovative interaction with the external fixation post, and is configured to automatically obtain the patient's prescription (including the date and / or time of the next adjustment step and possibly issuing a warning) associated with the tool from the cloud unit and also obtain feedback information (such as the actual length of the post) based on data communication with the post. Once connected to the post based on the downloaded prescription and feedback information, the above adjustment is then automatically performed. First, an operator (e.g., a surgeon) performs pairing of the tool with each post after downloading the prescription data. Thus, each post is uniquely associated with the tool (by a unique post ID) through data communication with the tool and can therefore be recognized by the tool. Next, the patient is properly guided through all operation steps and is only required to press a button on the tool to confirm and / or start a specific operation of the tool and to perform the adjustment operation. Since the post association has been previously made by the surgeon, an error message is generated if an incorrect post is engaged.

[0030] Based on the idea of ​​this solution, the above technical problem is solved by a tool for adjusting an external fixator strut, the external fixator strut having an adjustment mechanism for length adjustment and a second connection part, and the tool comprises: a first connection portion configured to be in data communication with the external fixation strut via a second connection portion; a controller including a command instruction, based on the command instruction, downloading prescription data related to the determined patient case from the external unit, the prescription data including instructions for performing an adjustment of the patient's external fixation post; enters a standby state awaiting coupling with the patient's external fixation post (i.e., pre-coupling) to communicate data therebetween via the first connection; the prescription download and pre-coupling may typically be performed by the surgeon (or by another suitable operator); After the tool is connected to the external fixator support, a connection state between the tool and the external fixator support is recognized (i.e., the connection between the tool and the external fixator support is recognized); communicating with the external fixation strut through the first connection portion based on the coupling state; and Once the connection is complete and data exchange with the external fixation strut is completed, wait for the date and / or time when the prescribed adjustment will be performed based on the prescribed data. a controller configured to: Equipped with.

[0031] More particularly, the present disclosure comprises the following additional optional features taken alone or in combination with each other:

[0032] According to aspects of the present disclosure, during pre-coupling, the controller can be configured to assign a strut ID to the external fixation strut.

[0033] According to aspects of the present disclosure, the prescription data may include a set of dates and / or times for subsequent adjustments to be performed on the external fixation post, as well as the extent of the adjustments to be performed.

[0034] According to aspects of the present disclosure, the controller can be configured to issue an alert when a prescribed adjustment date and / or time arrives.

[0035] According to aspects of the present disclosure, the state in which the controller waits for the date and / or time for the prescribed adjustment to be performed can be an idle state.

[0036] According to aspects of the present disclosure, when the date and / or time arrives for the adjustment of the post to be performed, the controller can be configured to enter a further waiting state awaiting a subsequent coupling (i.e., another coupling following the pre-coupling) to perform the prescribed adjustment to the external fixator post, the subsequent coupling involving mechanical engagement with the external fixator post. The subsequent coupling may be performed by the patient.

[0037] According to aspects of the present disclosure, after being mechanically engaged with the external fixator post in a subsequent coupling operation following a further wait state, the controller can be configured to perform the prescribed adjustment by a drive tool means configured to act on the adjustment mechanism of the external fixator post.

[0038] According to aspects of the present disclosure, during the subsequent coupling operation, the controller can be configured to obtain information about the external fixator strut from the external fixator strut, said information including at least a measurement indicative of the length of the external fixator strut, said length being used for feedback control to drive the tool according to the prescription data. Obviously, the strut length can also be read during pre-coupling by the surgeon.

[0039] According to one embodiment, the information may also include a prop ID.

[0040] According to aspects of the present disclosure, the controller can be configured to obtain measurements indicative of the length of the external fixator post from a sensor on the external fixator post, the data passing through the first connection.

[0041] According to aspects of the present disclosure, the controller can be configured to detect updates to the prescription data from the external unit and download the updates to replace previously downloaded prescription data with the updated prescription data.

[0042] According to aspects of the present disclosure, the controller can be configured to postpone performing the adjustment of the external fixation post after a user selection.

[0043] According to aspects of the present disclosure, if deferral is selected by the user, the controller can be configured to perform the deferred adjustment on the support during the next adjustment operation, with the amount of adjustment added during the next adjustment operation being determined based on the time elapsed since the last adjustment operation.

[0044] According to aspects of the present disclosure, the tool may include a push button configured to be engaged by a user to initiate, complete, or select an operational step of the tool.

[0045] According to aspects of the present disclosure, the tool may comprise means for communicating data with an external unit.

[0046] According to an aspect of the present disclosure, after completing the connection (both preliminary connection and subsequent connection) to one external fixation post, the controller can be configured to check whether other external fixation posts should be connected by the tool, and if yes, enter a standby state to wait for connection to said other external fixation posts.

[0047] According to aspects of the present disclosure, the controller can be configured to issue a warning if the patient couples (engages) the tool to the wrong post.

[0048] According to aspects of the present disclosure, the controller can be configured to generate interfaces on the display of the tool, the interfaces being constructed to indicate the respective operational states of the tool.

[0049] According to aspects of the present disclosure, the tool can include an output shaft and a motor operable to rotate the output shaft, the controller configured to drive the motor according to prescription data.

[0050] According to aspects of the present disclosure, the controller can be configured to monitor the rotation of the output shaft and estimate the gearbox reduction ratio between the motor and the strut of the tool.

[0051] According to aspects of the present disclosure, the tool may further include a first coupling rigidly attached to the output shaft and configured to releasably engage a corresponding second coupling of the adjustment mechanism of the strut, thereby enabling torque transmission from the motor to the adjustment mechanism, the first coupling being in electrical communication with the controller and configured to electrically connect with the second coupling when the first coupling engages with the second coupling, thereby enabling data transmission from the external fixation strut to the controller and vice versa.

[0052] According to aspects of the present disclosure, the tool may further comprise a power source, and an electrical connection between the first connection and the second connection further enables power transmission to the external fixation post.

[0053] The present disclosure also relates to an external fixation strut comprising: an elongate body having at least a first shaft and a second shaft, the first shaft and the second shaft being movable relative to each other to change the length of the elongate body; an adjustment mechanism for moving the second shaft relative to the first shaft, thereby changing the length of the elongate body; a second connection portion of the adjustment mechanism configured to releasably engage with a first connection portion of a tool as disclosed above (according to any one of the above features, alone or in combination) to enable torque transmission; at least one sensor configured to perform at least a measurement indicative of the length of the elongate body; and a second connection portion of the adjustment mechanism in electrical communication with the first connection portion of the programmable tool when the first connection portion is engaged with the second connection portion, the second connection portion configured to enable transmission of data from the sensor to the tool.

[0054] According to aspects of the present disclosure, the sensor may be a position sensor.

[0055] According to aspects of the present disclosure, the second connection can also be configured to receive a power signal from the tool.

[0056] The present disclosure also relates to a medical assembly, a tool as disclosed above, and one or more external fixation posts as disclosed above.

[0057] Features and advantages of the tools of the present disclosure will result from the description of one or more embodiments thereof given below with reference to the accompanying drawings. [Brief explanation of the drawings]

[0058] For a more complete understanding of the features and advantages of the present disclosure, reference is made to the detailed description of the disclosure taken in conjunction with the accompanying drawings.

[0059] [Figure 1] FIG. 1 is a side view of one embodiment of an external fixator post according to the present disclosure. [Figure 2]2 is a cross-sectional view of the external fixation strut taken along the section indicated by AA in FIG. 1. FIG. [Figure 3] 2 is a cross-sectional view of the external fixation strut taken along the cut plane indicated by BB in FIG. 1. [Figure 4] FIG. 1 is a side view of one embodiment of an external fixator post according to the present disclosure. [Figure 5] FIG. 5 is a cross-sectional view of the external fixation strut taken along the cut plane indicated by CC in FIG. 4. [Figure 6] FIG. 1 is a perspective view of one embodiment of an external fixation post according to the present disclosure. [Figure 7] FIG. 1 is a side view of a second embodiment of an external fixation post according to the present disclosure. [Figure 8] FIG. 8 is a cross-sectional view of the external fixation strut along the cutting plane indicated by DD in FIG. 7. [Figure 9] FIG. 8 is a cross-sectional view of the external fixation post taken along the cut plane indicated by EE in FIG. 7. [Figure 10] FIG. 1 is a side view of a second embodiment of an external fixation post according to the present disclosure. [Figure 11] FIG. 11 is a cross-sectional view of the external fixation strut along the cut plane indicated by FF in FIG. 10. [Figure 12] FIG. 1 is a perspective view of a second embodiment of an external fixation post according to the present disclosure. [Figure 13] FIG. 12 is an enlarged detailed view of the area indicated by G in FIG. [Figure 14] FIG. 12 is an enlarged detailed view of the area indicated by H in FIG. [Figure 15] FIG. 1 is a top view of one embodiment of a programmable tool according to the present disclosure. [Figure 16] FIG. 10 is a side view of an embodiment of an external fixator post adjacent to an embodiment of a programmable tool according to the present disclosure. [Figure 17] 17 is a cross-sectional view of the external fixation post adjacent to the programmable tool along the cutting plane indicated by II in FIG. 16. [Figure 18] FIG. 10 is a side view of an embodiment of an external fixator post adjacent to an embodiment of a programmable tool according to the present disclosure. [Figure 19]19 is a cross-sectional view of the external fixation post adjacent to the programmable tool along the section indicated at JJ in FIG. 18. [Figure 20] FIG. 20 is an enlarged detailed view of the area indicated by K in FIG. 19. [Figure 21] FIG. 1 shows a general scheme of a medical assembly according to the present disclosure, where a tool interacts with an external unit and an external fixation post. [Figure 22] FIG. 1 is a block diagram of an exemplary architecture and connections according to an embodiment of the present disclosure. [Figure 23A] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23B] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23C] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23D] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23E] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23F] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23G] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23H] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23I] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23J] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23K] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23L] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23M] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23N] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23O] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23P] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23Q] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23R] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23S] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23T] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23U] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23V] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 23W] 1 is an example of an interface displayed by a display of a tool according to an embodiment of the present disclosure. [Figure 24] 1 is a first half of a flowchart illustrating the operation of a tool according to an embodiment of the present disclosure. [Figure 25] This is the second half of the flowchart in Figure 24. DETAILED DESCRIPTION OF THE INVENTION

[0060] While the making 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 embodied in a wide variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways to make and use the present disclosure and do not limit the scope of the disclosure.

[0061] With reference to the above figures, a tool for adjusting an external fixator post according to the present disclosure is generally and schematically indicated by 100, while the external fixator post is generally and schematically indicated by 200.

[0062] It is worth noting that the figures represent schematic diagrams and are not drawn to scale, but instead are drawn to highlight important features of the present invention. Also, in the figures, various elements are depicted in a schematic manner, and their shapes may vary depending on the desired application. It is also noted that in the figures, the same reference numbers refer to elements that are identical in shape or function. Finally, certain features described in connection with the embodiments shown in the figures may also be applicable to other embodiments shown in other figures.

[0063] Obviously, as is well understood by those skilled in the art, some technical details of the present invention can be replaced by other technically equivalent details without departing from the scope of protection defined in the claims.

[0064] Also, where a sequence of process steps is shown, they do not necessarily have to follow the sequence shown; unless explicitly stated, the steps may be in reverse order.

[0065] The programmable tool 100 of the present disclosure is configured to adjust the external fixation strut 200 by implementing enhanced interaction with and communicating with external units, such as a cloud unit and / or a user device, as disclosed below.

[0066] FIG. 1 shows a schematic side view of an improved external fixation strut 200 according to the present disclosure, in which an elongated body 211 having opposite ends 215, 216 is configured to be attached to respective fixation rings or arches of a preferably hexapod-type external fixator device.

[0067] Rings of external fixators which can be fixed to bone sites via half pins or wires are known per se and are not shown in the accompanying figures.

[0068] The elongate 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 is composed of a hollow body 2120 that culminates with a first end 215 and a slider 2121 that slides within the body 2120 and receives the second tubular shaft 213.

[0069] The relationship between the two bodies of the first shaft 212 and the relationship between the first shaft and the second shaft 213 gives the entire strut 200 a telescopic configuration so that the length of the elongated body 211 can be adjusted as needed to maintain the interconnected rings in a predetermined relative spatial relationship.

[0070] In particular, the relationship between the body 2120 and the sliding body 2121, which defines the length of the first shaft 212, is changed in a first adjustment of the length between the two attachment points of the strut 200, while the relationship between the first shaft 212 and the second shaft 213 is changed to fine-tune the length of the strut, particularly in post-operative follow-up.

[0071] Body 2120 and slider 2121 are locked together by a locking screw 2122, which can be loosened to manually adjust the relative positions of these two elements.

[0072] On the other hand, the position of the second shaft 213 relative to the first shaft 212 is adjusted by a rotatable adjustment mechanism 201 housed in a casing 217 of the slide 2120 of the first shaft 212. The rotatable adjustment mechanism will be described in more detail with reference to FIG.

[0073] An external measurement cursor 219, firmly attached to the inner end of the second shaft 213 through legs that cross a longitudinal slit 220 in the casing 217, slides along a graduated scale 218 integral with the casing 217, thereby enabling visual assessment of the relative position of the second shaft 213 with respect to the first shaft 212.

[0074] To allow the user to view the graduated scale 218, the frame of the hollow body 2120 has open sides, at one end of which the frame is provided with a transverse bridge 221. The bridge 221 is visible against the background of the graduations 228, allowing a visual assessment of the relative position of the slide 2121 with respect to the body 2120, and thus the length of the first shaft 212.

[0075] FIG. 2 shows a cross-sectional view of the device of FIG.

[0076] The two ends 215, 216 of the strut 200 are provided with ball joints 218, which allow the strut 200 to articulate relative to the fixed ring or arch to which it is attached.

[0077] The rotation imparted by the rotatable adjustment mechanism 201 defines a sliding movement of the second shaft 213 relative to the first shaft 212 such that the second end 216 is pulled away from or towards the first end 215 due to the threaded connection.

[0078] FIG. 3 shows a cross-sectional view of the rotatable adjustment mechanism 201 described above.

[0079] The rotatable adjustment mechanism 201 comprises a worm gear mechanism having a worm screw 2010 that meshes with a worm gear 2011 that is coaxial with and threadedly engages a second shaft.

[0080] The worm screw 2010 has a worm screw shaft 2010 that is perpendicular to the axis of the elongated body 211 .

[0081] A protruding head 2013 protruding from the side wall of the casing 207 rotatably receives the screw shaft 2010 and defines a second coupling portion 203 for attaching a corresponding coupling portion of a wrench tool, as will be further described below.

[0082] The protruding head 2013 further defines an outer sleeve that surrounds the second coupling portion 203. In the illustrated embodiment, the outer sleeve has an inner circular profile and an outer hexagonal profile, the latter including an outer groove 210 for attachment of a locking mechanism of an adjustment tool.

[0083] FIG. 4 shows a schematic side view of an external fixation strut 200 according to the present disclosure, with other elements not shown.

[0084] FIG. 5 shows a cross-sectional view of the device of FIG.

[0085] A position sensor 214 is housed within the casing 217 and is rigidly attached to the casing 217 and extends along the inner longitudinal length of the first shaft 212 .

[0086] The position sensor 214 detects the absolute position of the end piece 222 of the second shaft 213 and / or the absolute position of the external measurement cursor 219 and returns measurements that can be used to assess the relative position of the second shaft 213 with respect to the first shaft 212.

[0087] This measurement can be used as feedback information when adjusting the length of the external fixation post 200 in the post-operative stage, as disclosed in detail below.

[0088] Preferably, the position sensor 214 is a capacitive sensor, although other alternatives such as inductive solutions can also be used. In either case, absolute sensors take precedence over relative sensors.

[0089] FIG. 6 shows a schematic perspective view of an external fixation strut 200 according to the present invention, without other elements being disclosed.

[0090] 7-12 show alternative embodiments of short sized external fixator posts relative to the long external fixator posts previously described.

[0091] In such alternative embodiments, the external fixation post has essentially the same components and major features as the longer embodiments previously described, and therefore such components and features are indicated in the figures by the previously used reference numerals and are not described again in the following paragraphs.

[0092] The main structural difference from the long-length case is that here the ball joint of the first shaft 212 is not located at its end 215, but at the opposite end of the hollow body 2120 of the first shaft 215, so that the two connection points defined by the ball joint 218 are located closer to each other.

[0093] 13 and 14 show specific details in the construction of the position sensor 214 previously described.

[0094] The position sensor's flexible signal wire 2141 connects the input pad 2140 or board to the body of the sensor 214, which extends adjacent the end piece 222 to be sensed.

[0095] 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, and this curvature is designed to maintain a radius above a threshold to avoid damaging the signal line during the manufacturing process.

[0096] To adjust the external fixation post, a programmable tool 100 is used, as disclosed in detail below with reference to FIG. 15 and subsequent figures.

[0097] FIG. 15 shows a top view of a programmable tool 100 according to the present disclosure in the form of a wrench, particularly a power wrench.

[0098] The wrench comprises a rigid outer casing 111 .

[0099] In the illustrated embodiment, the casing 111 has a generally cylindrical shape, but the shape of the casing 111 can be any shape and size that is convenient for use.

[0100] In the illustrated embodiment, the casing 111 defines a handpiece having a distal grip portion 112 with an ergonomic handle followed by a proximal interface portion 113 .

[0101] The casing 111 can have various connection ports, connectors, displays, and controllers.

[0102] In particular, in the illustrated exemplary embodiment, the interface portion comprises first and second push buttons 114 and 115, also identified herein as Button 1 and Button 2, and a display 116, and further has an indicator 120, such as a circular LED indicator (e.g., including an RGB LED), which can be lit in various colors and in a solid or flashing mode to inform the user of multiple operating states of the device.

[0103] In a preferred embodiment, the circular LED indicator can have up to four illumination states, respectively indicating a request for action from the user, an operation in progress with the wrench, and successful or unsuccessful completion of the wrench operation. In one embodiment, there can be additional states for the LED indicator, such as indicating a charging operation.

[0104] The device may further comprise a buzzer or any other audio device, and may also comprise near field communication (NFC) means for communication with other electronic devices, as well as wireless charging means, as described in more detail below.

[0105] The device further comprises a front muzzle 107 forward of the interface portion 113 , the front muzzle 107 being arranged to connect to a torque input port of a rotatable adjustment mechanism 201 of the external fixation post 200 .

[0106] FIG. 16 shows a side view of the programmable tool 100 being coupled to an external fixation post 200 .

[0107] FIG. 17 is a cross-sectional view of the two devices of FIG. 16, showing schematically the major components inside the casing 111 of the programmable tool 100.

[0108] The programmable tool 100 comprises a power source 106 in the form of a rechargeable battery, an electric motor 102 preferably comprising a gearbox in-line with a coaxial output shaft 101, and a controller 104, for example in the form of a PCB. The controller 104 is configured to manage the operation of the tool 100 and is not limited to a particular configuration.

[0109] The programmable tool 100 may also include an internal memory that can be conveniently used to store the patient's prescription and the actual lengths of the struts that make up the external fixator to be adjusted by the tool 100. In any case, the present disclosure is not limited by the structure of the tool memory, which may be an integral part of the controller 104 or a separate memory portion operatively connected to the controller 104.

[0110] The programmable tool 100 further comprises means for data communication with an external unit, in particular an external data source, for example in the form of a data port and / or a wireless connection (herein referred to as "TX"). Preferably, the programmable tool has a SIM housing (not shown) for providing the device with an Internet connection, although any suitable means may be used for this purpose. Such means TX may comprise, for example, a Bluetooth or Wi-Fi connection port as well as the above-mentioned NFC means for connection with a user device or other external devices.

[0111] In some embodiments, means for wireless charging may be provided.

[0112] The controller 104 of the programmable tool 100 is configured to communicate with an external unit, in particular a cloud unit, either directly or via a portable electronic user device such as a smartphone, to obtain the surgeon's prescription and update the status including at least the length of the several external fixation struts 200 of the external fixator, as disclosed below with reference to Figures 21 to 25.

[0113] The controller 104 is connected to push buttons 114 and 115, a display 116, and a circular LED indicator to read the user's commands, communicate status updates, or guide the user through the process of adjusting all the struts 200 according to a given prescription.

[0114] The muzzle 107 of the programmable tool 100 houses an output shaft 101 which terminates in a first coupling part 103 in the shape of a wrench socket, in particular in the shape of a hexagonal socket.

[0115] The muzzle further includes a locking mechanism 109 operable to secure and selectively release engagement between the first coupling portion 103 and 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 recess 108 of the muzzle 107, best seen in FIG.

[0116] The locking mechanism 109 is defined by the body of the muzzle 107, which can be retracted towards the housing 111 of the programmable tool 100 by pressing against a resilient means, which can be in the form of a spring 1090, as best shown in Figure 20. The muzzle 107 has therein a latch element 110, which can be in the form of a roller that moves along a diagonal path, the roller being externally biased by the action of the spring 1090 to engage.

[0117] Furthermore, the tool 100 comprises a first connection portion 105 (eg, arranged around the first coupling portion 103 ) for electrically connecting with a second connection portion 205 of the strut 200 .

[0118] When the locking mechanism 109 is engaged, the first connection 105 connects to the second connection 205 of the support 200, providing a data connection that allows the controller 104 to obtain data from the sensor 214.

[0119] The electrical connection ensures power supply from the power source 106 to the sensor 214 .

[0120] FIG. 18 shows a further side view of the programmable tool 100 being coupled to an external fixation post 200 .

[0121] FIG. 19 is a cross-sectional view of the two devices of FIG.

[0122] FIG. 20 is an enlarged view of FIG. 19 showing details of the first connector 105 according to an exemplary embodiment of the present disclosure.

[0123] The first connection portion 105 comprises a number of inner connectors 1050, preferably in the form of pogo pins, at the bottom of the annular recess 108 for connecting the first electrodes.

[0124] Furthermore, the first connection portion 105 preferably comprises a plurality of outer connectors 1051 in the form of clips or leaf spring connectors protruding from the outer side of the annular recess 108. The outer connectors 1051 are for connecting a second electrode.

[0125] In use, the inner connector 1050 contacts the inner surface 2050 of the outer sleeve of the protruding head 2013, while the outer connector 1051 contacts the outer surface 2051 of the outer sleeve. As best shown in Figure 9, the inner surface 2050 and the outer surface 2051 are separated by a dielectric layer 2052.

[0126] To improve the interaction between the tool 100 and the external fixation strut 200, according to the present disclosure, the controller 104 advantageously comprises a set of instructions that, when executed, cause the tool 100 to automatically perform the operations disclosed below.

[0127] 21 shows a general configuration of a medical assembly 1000 including a tool 100 and an external fixator post 200 having the above-disclosed rotatable adjustment mechanism 201 for length adjustment. As described above, the external fixator post 200 includes a second connection portion 205 for data communication with the tool 100. Meanwhile, the tool 100 includes a first connection portion 105 configured for data communication with the external fixator post 200 via the second connection portion 205.

[0128] Therefore, as described above, the first connection 105 and the second connection 205 also enable data transmission between the external fixation column 200 and the controller 104 of the tool 100, for example, data transmission from a sensor of the external fixation column 200 to the controller 104.

[0129] In operation, the controller 104 is configured to first associate the tool 100 with a particular patient case. For example, the controller 104 may load information about the patient into the memory of the tool 100 and allow that information to be recalled when needed (e.g., upon powering on the tool 100, when this association phase begins). The surgeon (or any other suitable operator) may then confirm the association and proceed to the next operational step, for example by pressing one of the pushbuttons (e.g., button 1) on the tool 100. In this manner, this initial association is performed and confirmed by the surgeon, and the tool is set up for its next use with the patient.

[0130] Preferably, once the controller 104 is associated with a particular patient, it is configured to download prescription data (hereinafter "DATA") relating to that patient from an external unit, such as a cloud unit (designated by reference numeral 300), as described above. In some embodiments, the download may occur automatically.

[0131] The external unit 300 may for example be a web server to which the tool 100 has direct or indirect access via its means TX.

[0132] For example, the tool 100 can be connected via means TX to a user device 310, such as a smartphone, which is equipped with an appropriate application or has access to a dedicated internet portal for performing the connection with the external unit 300 and downloading prescription data DATA to the tool 100, in particular to its memory.

[0133] Thus, the download of data can occur directly through the tool 100 itself or indirectly through the user device, and this also applies to subsequent updates that are downloaded.

[0134] The prescription data DATA relates to the patient case with which the tool 100 is associated and includes information and instructions for performing the adjustment of the patient's external fixation strut 200, such as a set of dates and / or times when the adjustment of the external fixation strut 200 should be performed, as well as the degree of adjustment, for example, in terms of strut length per adjustment step.

[0135] It can be seen that each prescription has an expiration date, if the prescription is not downloaded within the expiration date, it will be invalid and no further treatment will be allowed.

[0136] Once the download is complete, the surgeon (or any other suitable operator) can confirm by pressing one of the push buttons (e.g., button 1) on tool 100. Thus, in a typical setup operation, the surgeon confirms that the prescription data DATA download was successful, as described above. As will be described below, if the prescription is updated, the patient can receive the update (e.g., via a mobile app), confirm the download of the updated prescription, and then confirm its success.

[0137] Once the above preliminary operations (i.e., preliminary association and prescription download) have been completed by the surgeon (or any other suitable operator), for example after further pressing one of the push buttons, the controller 104 puts the tool 100 into a standby state, in which it waits for preliminary connection with the patient's external fixation strut 200, in particular data communication with the patient's external fixation strut 200 via the first connection 105.

[0138] Even in this case, this preliminary connection is performed by the surgeon (or any other suitable operator), and in particular, after the tool 100 is connected to the external fixation column 200 in the preliminary connection operation, the controller 104 can automatically recognize the connection status between the tool 100 and the external fixation column 200 and notify this connection status.

[0139] Based on this coupling, the controller 104 then communicates with the external fixation strut 200 via the first connection 105 and the second connection 205, in particular performing data communication.

[0140] In particular, during this preliminary coupling, the controller 104 can write an ID into the strut memory in order to provide a unique ID to a new strut or to re-code an incorrectly coded strut. In other words, during the above-mentioned preliminary coupling, the controller 104 is configured to assign a strut ID to the external fixator strut 200 in order to identify the external fixator strut 200.

[0141] During this connection, it is also possible to exchange other preliminary information with the pole (for example, reading the ID if one has already been assigned, reading the length of the pole, etc.; more on this below).

[0142] Next, after coupling with the external fixation post 200 and exchanging preliminary information (i.e., after the preliminary coupling described above), the tool 100 (i.e., its controller 104) enters an idle state where it waits for the prescribed time / date for the adjustment of the post to be performed (e.g., after an additional push of the push button after the coupling is complete).

[0143] In this idle state, the patient can also confirm the next adjustment date / time, for example, by pressing a push button on the tool 100 .

[0144] When the date and / or time for the post adjustment arrives, the tool 100 can issue a warning (visual and / or audible warning) and the patient can press a push button (e.g., button 1) on the tool 100. Thereafter, the controller 104 is configured to transition the tool 100 to a further waiting state in which it awaits a subsequent mechanical coupling with the external fixator post 200 in order to perform the prescribed adjustment to the post 200. The subsequent coupling operation involves a mechanical engagement between the tool 100 and the external fixator post 200 and is typically performed by the patient.

[0145] The controller 104 is configured to wake-up the tool 100 for future operations. In one embodiment, waking up the tool 100 is performed using an internal RTC.

[0146] In one embodiment, if there is an upcoming procedure, the controller 104 is also programmed to estimate the power-budget required to complete the entire procedure.

[0147] Then, when the tool 100 is mechanically engaged by the patient to the external fixator post 200, the controller 104 is configured to automatically perform the prescribed adjustment by driving dedicated means of the tool 100 that act on the rotatable adjustment mechanism 201 of the external fixator post 200. More specifically, the controller 104 is configured to drive the motor 102 of the tool 100 according to the prescription data DATA to perform the appropriate adjustment on the post 200. As will be explained below, the length of the external fixator post 200 can be used to control the driving means of the tool 100.

[0148] Once the tool 100 is engaged with the external fixation post for correction, the patient is notified that the tool has successfully adjusted the incremental length of the post, and the tool can be returned to the idle state by pressing the push button (e.g., button 1) again.

[0149] Typically, a fixation device comprises multiple struts, for example, six struts. Therefore, after completing coupling with one external fixation strut, the controller 104 is configured to check whether another external fixation strut is to be engaged by the tool 100, and if yes, to put the tool 100 into a standby state waiting for coupling with said other external fixation strut (for example, after pressing a push button). This applies to both preliminary coupling performed by the surgeon and mechanical engagement performed by the patient, and the patient is accurately guided and errors are avoided by the prior pairing and the generation of error messages.

[0150] Thus, in one embodiment, after the surgeon has performed a preliminary pairing of the tool 100 with the posts 200, the tool 100 knows the exact identity of each post 200 of the external fixation device (e.g., correct post 1, post 2, etc.). Thus, if the patient has inserted the wrong post, the tool 100 is configured to provide feedback to the user and warn them in the form of an error message so that the patient knows that they have inserted the wrong post.

[0151] When the patient engages the post 200 with the tool 100, the tool 100 obtains useful information (referred to herein as "INFO") from the external fixation post 200, such as its length.

[0152] In one embodiment, the actual length of the external fixator post 200 is obtained by the controller 104 by reading data from the position sensor 214 of the external fixator post 200 .

[0153] Thus, the information INFO (exchanged during the subsequent coupling performed by the patient) can relate to a measurement indicative of the length of the external fixation post 200, and the controller 104 is configured to obtain at least said length from the position sensor 2014 of the external fixation post 200 when the tool 100 is coupled to the external fixation post 200. This value can then be used in a subsequent adjustment step for feedback control when driving the tool 100 according to the prescription data DATA.

[0154] Furthermore, other information may be exchanged as part of the information INFO, such as a post ID for identifying the external fixation post 200 or any other useful information.

[0155] As mentioned above, the tool 100 is configured to issue a warning when the prescribed adjustment date and / or time arrives, allowing the patient to quickly couple the tool 100 to the post 200 when needed. However, the user can also postpone performing the adjustment of the external fixation post 200 when the warning is issued, for example, by pressing one of the push buttons on the tool 100. In one embodiment, pressing push button 1 puts the tool into a standby state awaiting coupling to the post, and pressing button 2 postpones the adjustment.

[0156] More particularly, in one embodiment, if a correction is to be performed and a warning is issued, the controller 104 is programmed so that the patient has the following options: All corrections will be implemented immediately. Partial correction is carried out immediately. Snooze tool warnings and postpone remediation without performing any remediation until the next remediation. The warning is suspended and the correction is postponed, and the correction is performed at any time between the postponed operation and the next adjustment to be made.

[0157] If a remediation is postponed and no user action is taken until the next remediation, the postponed remediation will be automatically performed at the next remediation step. In this case, the postponed remediation is added to the standard remediation to be performed at the next remediation step. In one embodiment, if a postponement is selected (or a partial remediation is performed), the amount of remediation added at the next remediation step is determined based on the time elapsed since the last remediation.

[0158] Furthermore, as mentioned above, according to one embodiment of the present disclosure, the controller 104 is configured to detect updates to the prescription data DATA from the external unit 300 and download said updates directly to its memory or indirectly via the user device 310, replacing previously downloaded prescription data with the updated prescription data so that the appropriate prescription is always applied.

[0159] It is therefore clear that automating the operation of tool 100 avoids patient error, improves the overall post-operative adjustment process, and properly guides the patient through all steps of the operation of tool 100.

[0160] FIG. 22 is a block diagram of an exemplary configuration and connections according to an embodiment of the present disclosure, with only data connections shown for clarity.

[0161] In the illustrated embodiment, the controller 104 of the tool 100 comprises a main board 600 that integrates appropriate software modules for implementing the functionality of the tool 100 disclosed above.

[0162] A communications module 601 is configured to establish a communications protocol with the stanchion 200. Communications between the tool 100 and the stanchion 200 can occur over a dc coupling bus over which both power and data are transmitted. In one embodiment, communications occur over a half-duplex serial bus, with data being written to or read from the stanchion 200.

[0163] Two main functions are performed by the communications module 601: writing an identification code to give a new post an identification ID or to re-code an incorrectly coded post (this operation is performed by the surgeon or any other suitable operator as indicated above), and reading the post ID (this is performed in both surgeon mode and patient mode to read the ID of the post after it has been coupled to a tool).

[0164] The communication module 601 is also configured to be able to read the length and position of the pole via the pole sensor.

[0165] The controller 104 is also programmed to implement a power management module 602 configured to manage all power paths of the tool 100 .

[0166] The controller 104 is also programmed to implement a USB data connection module 603 and a motor management / encoder module 604 .

[0167] More specifically, the motor management / encoder module 604 is configured to ensure that the motor (which may be a brushed motor) is driven correctly. The motor driving hardware detects motor faults / overloads, sets the speed, and verifies that the target speed is achieved via a closed-loop PID. Specifically, motor acceleration and deceleration ramps are implemented, and the above operation is controlled by a closed-loop PID via readings from feedback Hall sensors.

[0168] Additionally, a buzzer / LED ring module 605 is implemented as part of the safety module and is configured to notify the operator / patient when an error, warning, or notification occurs, as described above. The audio signals can have a predetermined pattern that can change depending on the situation, and these audio signals correlate with the color of the corresponding LED. The LED ring 120 is driven by a serial concatenated bus (shift register) that facilitates sending color and brightness information to the LEDs. This is done so that the appropriate color is always displayed depending on the alarms active on the system.

[0169] The software modules then include a keyboard management module 606 configured to recognize presses of the push buttons of the tool 100 and to trigger appropriate actions.

[0170] The software modules then include an external flash and RAM module 607 and a display module 608 .

[0171] Additionally, the connectivity module 609 is configured to allow connection to external devices 300, for example, to check for new firmware updates, check for new prescriptions, upload the latest life counters, logs, or data that needs to be loaded to the cloud, receive commands to enable some particular operating mode of the tool 100 (e.g., service mode or surgeon mode), etc.

[0172] Finally, the safety module 610 is configured to ensure proper and safe operation of the tool.

[0173] As part of the safety module, the prescribed extension amount is monitored during the procedure from both the data readout from the sensor on the strut and the rotation of the motor shaft. Appropriate calculations are performed taking into account the gearbox reduction ratio between the motor 102 of the tool 100 and the strut. If the values ​​do not fit within predetermined thresholds, the controller is configured to switch the tool 100 into a safety 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 of the tool 100 and the strut 200.

[0174] The controller 104 may also be configured to generate interfaces I1-I23 on the display 116 of the tool 100, which interfaces I1-I23 are configured to indicate the respective operational states of the tool 100.

[0175] Figures 23A-23W show examples of interfaces that may be displayed on a display of a tool according to an embodiment of the present disclosure, and are described below in conjunction with Figures 24 and 25.

[0176] 24 and 25 show the first and second halves of a flow diagram of the operation of tool 100 as disclosed above in connection with FIG.

[0177] In summary, the above device can be switched from an off state 500 to an on state 501 by a user, for example, by pressing button 1 or button 2 for a certain period of time. This may correspond to the transition from interface I1 in Figure 23A to interface I2 in Figure 23B.

[0178] A similar action from the user may be required to return the device to the off state 500.

[0179] After a certain time after powering on, the device becomes associated with a particular case 502, as represented by interfaces I3, I4, and I5 in Figures 23C, 23D, and 23E.

[0180] Then, after a command by the user, the device connects to the Internet, retrieves the prescription data DATA of the patient's case 503 from a dedicated portal, and notifies the patient once the prescription has been successfully transferred to the tool memory, which is represented by interfaces I6, I7, and I8 in Figures 23F, 23G, and 23H.

[0181] As mentioned above, there are multiple ways to connect directly or indirectly to the external unit 300 (eg, GSM, BT, NFC, WiFi), and the present disclosure is not limited by the communication means employed.

[0182] After the prescription is uploaded to the internal memory, the device goes into a general standby state 504, which may be communicated to the user via the display 116 and / or the circular LED indicator, as shown in interface I9 of FIG. 23I.

[0183] Upon receiving a user command, such as pressing Button 1, the device enters a waiting to connect state 505 and indicates via display 116 that it is ready to connect to a particular pole, as shown in interface I10 of FIG. 23J.

[0184] In the Waiting to Connect state 505, the user is expected to mechanically connect the device to the support 200, which will establish a data connection as described above. When the tool is connected to the support, it indicates this via interface I11 in Figure 23K, and once the connection is complete, it indicates this via interface I12 in Figure 23L.

[0185] Once the data connection is established (507), the device then suggests to the user other poles 200 that can be connected in a similar manner.

[0186] Once all the struts 200 are properly connected, the device will be in the connected state 508 as shown at interface I13 in FIG. 23M.

[0187] Thereafter, upon command from the user, the device enters an idle state 509 (interface I14 in FIG. 23N) ready to send a signal when the prescribed correction date and / or time 510 arrives. In this state, the user can interrogate the device, for example by pressing button 1, and the device will display the next correction date and time 511 (interface I15 in FIG. 23O).

[0188] Then, when the time for correction 510 finally arrives, the user may be notified via an audible and / or visual signal that action needs to be taken (as indicated by interface I16 in FIG. 23P).

[0189] The user is then given the option to either adjust the pole or postpone it 512. Button 1 and Button 2 can be used interchangeably to distinguish between the two options.

[0190] If the user decides to perform the correction, the device then guides the user to engage (513) the post 200 to be adjusted (interface I17 in FIG. 23Q). Once the external fixation post 200 is engaged, the device automatically performs the adjustment in an adjustment step 514 and then notifies the user that the adjustment is complete (515) (interfaces I18 and I19 in FIGS. 23R and 23S).

[0191] If another strut needs to be adjusted, steps 513-515 are repeated. Otherwise, the device notifies the user that the correction is complete (516) (interface I20 in FIG. 23T) and returns to idle state 509.

[0192] From the idle state 509, the device can also update the prescription 517 whenever an update to the prescription is detected (see interfaces I21, I22, and I23 in Figures 23U, 23V, and 23W). This update can be activated by the patient by pressing a push button when the tool is in the idle state, or can be performed automatically by the tool 100 by periodically checking for updates, for example by interacting with the external unit 300.

[0193] In one embodiment, the patient or surgeon can engage the tool 100 with a particular strut 200 at any time (except during the correction phase) to obtain the strut length (state 518), and by pressing one or more buttons, the controller 104 is configured to initiate a test of the strut 200 (state 520) to ensure that both the strut mechanics and firmware are operating as expected.

[0194] Additionally, in one embodiment, during the strut adjustment operation, the patient can disengage the tool 100 from the strut 200 (state 522) as a safety mechanism if pain is experienced during the procedure.

[0195] It will be understood that the specific embodiments described herein are shown by way of illustration and not as limitations of the disclosure. The principal features of this disclosure can be employed in various embodiments without departing from the scope of the disclosure. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, numerous equivalents to the specific devices and procedures described herein. Such equivalents are considered to be within the scope of this disclosure and covered by the claims.

[0196] All publications and patent applications mentioned in this specification are indicative of the level of skill of those skilled in the art to which this disclosure pertains. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0197] In the claims and / or this specification, the use of the word "a" or "an" when used in conjunction with the term "comprising" may mean "one," but is also consistent with the meanings of "one or more," "at least one," and "one or more than one." The use of the term "or" in the claims is used to mean "and / or" unless expressly indicated to refer to alternatives only or unless the alternatives are mutually exclusive, although the present disclosure supports definitions that refer only to alternatives and "and / or."

[0198] As used in this specification and the claims, the terms "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.

[0199] Obviously, those skilled in the art may make various modifications and variations to the above tools to meet their particular fortuitous needs, and all such modifications and variations are within the scope of the present invention as defined by the appended claims.

Claims

1. A tool (100) for adjusting an external fixation post (200), comprising: The external fixation strut (200) has an adjustment mechanism (201) for adjusting the length and a second connection part (205), The tool (100) comprises: a first connection portion (105) configured to be in data communication with the external fixation strut (200) via the second connection portion (205); a controller (104) including a command instruction, based on which: downloading from the external unit (300) prescription data (Data) related to the determined patient case, the prescription data (Data) including instructions for performing an adjustment of the external fixation post (200) for said patient; entering a standby state awaiting coupling with the external fixation post (200) of the patient for communicating data therebetween via the first connection (105); After the tool (100) is connected to the external fixation strut (200), the connection state with the external fixation strut (200) is recognized. communicating with the external fixation strut (200) via the first connection portion (105) based on the connection state; and a controller (104) configured to, once said connection is complete and data exchange with said external fixation strut (200) is made, wait for a date and / or time for a prescribed adjustment to be performed based on said prescription data (DATA); A tool (100) comprising:

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

3. said prescription data (DATA) including a set of dates and / or times of subsequent adjustments to be performed on said external fixation strut (200) and the extent of said adjustments; The tool (100) of claim 1 or 2, wherein the controller (104) is configured to issue an alert when the prescribed adjustment date and / or time arrives.

4. The tool (100) of any one of claims 1 to 3, wherein the state in which the controller (104) waits for the date and / or time for the prescribed adjustment to be performed is an idle state.

5. The tool (100) according to any one of claims 1 to 4, wherein when the date and / or time for performing the adjustment of the post arrives, the controller (104) is configured to enter a further waiting state awaiting a subsequent coupling to perform the prescribed adjustment to the external fixator post (200), the subsequent coupling involving a mechanical engagement with the external fixator post (200).

6. 6. The tool (100) of claim 5, wherein after being mechanically engaged with the external fixation post (200) after the further waiting state, the controller (104) is configured to perform the prescribed adjustment by driving tool means configured to act on the adjustment mechanism (201) of the external fixation post (200).

7. 7. The tool (100) according to claim 5 or 6, wherein during the subsequent coupling, the controller (104) is configured to obtain information (INFO) about the external fixator strut (200) from the external fixator strut (200), said information (INFO) including at least a measurement indicative of a length of the external fixator strut (200), said length being used for feedback control to drive the tool (100) according to the prescription data (DATA).

8. 8. The tool (100) of claim 7, wherein the controller (104) is configured to obtain measurements indicative of a length of the external fixator strut (200) from a sensor (214) of the external fixator strut (200), the data passing through the first connection (105).

9. The tool (100) of any one of claims 1 to 8, wherein the controller (104) is configured to detect updates to the prescription data (DATA) from the external unit (300) and to download the updates to replace previously downloaded prescription data with updated prescription data.

10. The tool (100) of any one of claims 1 to 9, wherein the controller (104) is configured to postpone execution of the adjustment of the external fixation post (200) after a user selection.

11. 11. The tool (100) of claim 10, wherein if postponement is selected by the user, the controller (104) is configured to perform the postponed adjustment on the support (200) during a next adjustment operation, and the amount of adjustment to be added during the next adjustment operation is determined based on the elapsed time since the last adjustment operation.

12. the tool (100) comprises push buttons (Button 1, Button 2) configured to be engaged by a user to initiate, complete or select an operational step of the tool (100); The tool (100) comprises means (TX) for communicating data with the external unit (300), A tool (100) according to any one of claims 1 to 11.

13. The tool (100) according to any one of claims 1 to 12, wherein after completing the coupling with one external fixator strut, the controller (104) is configured to check whether another external fixator strut should be coupled by the tool (100), and if yes, enter a waiting state to wait for coupling with the other external fixator strut.

14. The tool (100) of claim 13, wherein the controller (104) is configured to issue a warning if the patient engages the tool (100) with an incorrect post.

15. the controller (104) is configured to generate interfaces (I1-I23) on a display (116) of the tool (100); said interfaces (I1-I23) being constructed to indicate the respective operational states of said tools (100); A tool (100) according to any one of the preceding claims.

16. The tool (100) comprises: an output shaft (101); a motor (102) operable to rotate said output shaft (101); Equipped with The controller (104) is configured to drive the motor (102) according to the prescription data (DATA). A tool (100) according to any one of the preceding claims.

17. 17. The tool (100) of claim 16, wherein the controller (104) is configured to monitor rotation of the output shaft (101) and estimate a gearbox reduction ratio between the motor (102) and a support (200) of the tool (100).

18. the tool (100) further comprises a first coupling (103) rigidly attached to the output shaft (101), the first coupling (103) configured to releasably engage a corresponding second coupling (203) of the adjustment mechanism (201), thereby enabling torque transmission from the motor (102) to the adjustment mechanism (201) of the column (200); the first connection portion (105) is configured to be in electrical communication with the controller (104) and to electrically connect with the second connection portion (205) when the first coupling portion (103) is engaged with the second coupling portion (203), thereby enabling data transmission from the external fixation strut (200) to the controller (105) and vice versa; The tool (100) according to claim 16 or 17.

19. It further comprises a power source; The electrical connection between the first connection portion (105) and the second connection portion (205) further enables power transmission to the external fixation strut (200). The tool (100) of claim 18.

20. an elongate body (211) comprising at least a first shaft (212) and a second shaft (213), said first shaft (212) and said second shaft (213) being movable relative to each other to change the length of said elongate body (211); an adjustment mechanism (201) for moving the second shaft (213) relative to the first shaft (212) to thereby change the length of the elongated body (211); a second coupling (203) of the adjustment mechanism (201) configured to releasably engage with a first coupling (103) of the tool (100) of any one of claims 1 to 19 to allow torque transmission; and at least one sensor (214) configured to provide at least a measurement indicative of the length of the elongated body (211); a second connection (205) of the adjustment mechanism (201) in electrical communication with the first connection (105) of the tool (100) when the first connection (103) is engaged with the second connection (203), the second connection (205) being configured to enable transmission of data from the sensor (214) to the tool (100); An external fixation strut (200) comprising:

21. The external fixation strut (200) of claim 20, wherein the sensor (214) is a position sensor.

22. The external fixation strut (200) according to claim 20 or 21, wherein the second connection (205) is also configured to receive a power signal from the tool (100).

23. A tool (100) according to any one of claims 1 to 19, One or more external fixation struts (200) according to any one of claims 20 to 22, A medical assembly (1000) comprising:

Images