Tool for adjusting an external fixation post, an adjustable external fixation post, and a kit including the fixation post and the tool

Abstract

The present disclosure relates to an external fixation strut (200'), comprising an elongated body (211) having at least a first shaft (212) and a second shaft (213) movable relative to each other to change the length of the elongated body (211), and at least one sensor (214') incorporated into the external fixation strut (200') and configured to perform at least a measurement indicative of the length of the elongated body (211), the sensor (214') communicating with a programmable tool through a data port engageable by the programmable tool to extend / shorten the external fixation strut (200').

Description

[Technical Field]

[0001] The present disclosure relates to the general field of external fixation, and more specifically to connections between external fixation posts and specialized tools used for incremental or decremental adjustment of such posts during the pre-operative, intra-operative, and post-operative periods. [Background technology]

[0002] Without limiting the scope of this disclosure, this specification provides background on external fixation devices and associated tools for adjusting the struts or other connecting rods of the devices.

[0003] External fixation devices are commonly used in various surgical procedures, such as limb fracture fixation, bone lengthening, and deformity correction. This process involves the application of a rigid framework. This framework can be a circular system, such as a hexapod system, and / or a circular system with multiple struts. Such systems typically include multiple rings or arches attached to each segment of the bone, positioned externally around the limb, using wires and half pins inserted into each segment and connected to the associated segment of the external rigid framework. Monolateral systems, such as a monolateral rail or a monolateral unibody, can also be used.

[0004] The opposing rings of the rigid framework are interconnected by threaded and / or telescoping posts either directly or in combination with single- or multi-planar hinges, allowing the relative positions of the rings 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 each compartment above and below the surgical osteotomy 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 whose length can be periodically adjusted to gradually separate the bone segments longitudinally.

[0007] The rigid framework is used to gradually separate the two bone compartments longitudinally over a period of time (e.g., 1 mm per day), allowing new bone to gradually form in the gap between the bone compartments created by this distraction technique. Once the desired bone distraction is achieved (e.g., 5-6 cm), the external device is secured in a fixed position and left on the bone compartments until the newly formed bone is fully mineralized (e.g., 3-6 months, depending on the nature of the condition and / or the amount of bone distraction).

[0008] Similarly, in deformity correction, the 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 osteotomy and attached to rings of a rigid framework. Again, the rings on opposite sides of the rigid framework are interconnected by hinges and threaded posts with attached angular distractors that are used to gradually angularly separate the two bone compartments over a period of time.

[0009] One common fixation device is a circular metal structure called 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 their associated bone segments apart.

[0010] Another common external fixator device is known as the Taylor Spatial Frame, a hexapod external fixator based on the so-called Stewart platform, but which 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. The struts have multi-plane hinges at both ends. Each strut can be extended or retracted as needed to move the two interconnected ring segments toward or away from each other.

[0012] Other examples of this type of 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 each bone segment, 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 other adjustments are scheduled. 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 the process is prone to human error. Patients are expected to check the length of the braces to ensure that the prescription matches the frame condition, but neglecting to do so or not checking at all can allow errors to go unnoticed.

[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 easy to understand that errors in implementing the prescription, especially if not immediately identified by the surgeon, can have a negative impact on the final outcome of the correction process.

[0020] To mitigate these drawbacks, programmable tools for incrementally adjusting the length of external fixator struts have been proposed in recent years. For example, prior art document WO 2009 / 105479, filed in the name of Texas Scottish Rite Children's Hospital, describes a tool designed as a powered wrench that engages the adjustment mechanism of the external fixator strut. The tool has an internal memory that stores prescription adjustment parameters and is configured to automatically adjust each strut according to these parameters.

[0021] Although programmable tools offer many advantages over the prior art techniques mentioned above, drawbacks remain, particularly with regard to ease of use of the device.

[0022] Indeed, to correctly adjust the strut length parameters according to the stored prescription, it is recommended that real-time measurements of the strut length be input into the tool. If the tool were to perform length increases or decreases according to the prescription without feedback, the adjustment process would easily be flawed by 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 application of the adjustment plan over time.

[0023] Therefore, it is preferable that the programmable tool be equipped with a means for measuring 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 difficult and prone to human error. Prior art devices are disclosed in US Patent Application Publication Nos. 2008 / 051779 and 2002 / 010465.

[0024] The technical problem underlying the present invention is to provide a new system for adjusting external fixation that overcomes or at least mitigates the disadvantages identified with the prior art.

[0025] The primary objective of the improved system of this disclosure is to increase automation of the adjustment process without burdening the user with additional tasks such as identifying pole numbers and externally measuring pole lengths, while streamlining the system's design and making it more cost-effective. Summary of the Invention

[0026] The solution idea underlying this disclosure is to provide an internal sensor inside the external fixator strut to measure the length of the strut, which communicates directly via a data port with a programmable tool for lengthening / shortening the strut.

[0027] According to this solution, the technical problem behind the present invention is solved by an external fixation strut comprising an elongate body having at least a first shaft and a second shaft movable relative to each other to change the length of the elongate body, and at least one sensor integrated into the external fixation strut and configured to perform at least a measurement indicative of the length of the elongate body, wherein the sensor communicates with a programmable tool via a port engageable by the programmable tool.

[0028] In a preferred embodiment, the data port is also used to power the sensor.

[0029] This has the advantage that the external fixation strut does not need an internal power source such as a battery, since an external power source is sufficient to perform measurements when required, i.e. during operation of the programmable tool.

[0030] In a preferred embodiment, the sensor is an absolute sensor rather than a relative sensor, that is, it returns an absolute position rather than an increment or decrement for each operation of the programmable tool.

[0031] aboveThe sensor may use either inductive or capacitive technology to determine the position of the moving element, with the best mode of the invention employing inductive technology.

[0032] The moving element to be sensed is an end piece of the second shaft and / or a measurement cursor moving with said end piece relative to the second shaft. be .

[0033] end The piece is slidable within the tubular body of the first shaft. In particular, the end piece may be a movable nut rotatably connected to the inner free end of the threaded shank of the second shaft.

[0034] In the case of sensors using inductive technology, the sensed element is preferably a measurement cursor attached to the end piece.

[0035] In one embodiment, such a measurement cursor is located outside the tubular body of the first shaft and emerges from a longitudinal slit in the tubular body, such a solution provides better sensitivity since the measurement is not influenced by the surrounding tubular body.

[0036] In another embodiment, at least a majority of the measurement cursor is contained within the tubular body of the first shaft. This embodiment requires fine adjustment of the sensor to cancel noise from surrounding objects, but is preferred because the internal measurement cursor is less likely to break and does not interfere with the visibility of the external indicia.

[0037] Preferably, the measurement cursor is at least partially housed within a longitudinal slit in the tubular body of the first shaft, said longitudinal slit extending in the longitudinal direction of the strut.

[0038] Preferably, the measurement cursor engages with the end piece via a groove and tooth structure extending laterally perpendicular to the longitudinal direction of the support so that the measurement cursor can be attached by inserting it into the longitudinal slit.

[0039] Such a solution is particularly advantageous as it simplifies the manufacture of the external fixation strut.

[0040] S The sensor has a sensor strip disposed within the tubular body of the first shaft.

[0041] If a measurement cursor is present, it slides over the sensor strip.

[0042] S The sensor strip is a flexible printed circuit board that is attached to the top of a rigid support plate.

[0043] The use of a rigid support plate simplifies the manufacture of the device as the sensor strip can be attached to the plate prior to insertion into the tubular body.

[0044] Tsuyoshi The magnetic support plate is made of a ferromagnetic material, such as ferrite, which at least partially insulates the sensor strip from external noise.

[0045] As mentioned above , th The tubular body of the shaft of the sensor element 1 has a longitudinal slit along it, which allows the sensor strip and rigid support plate to be inserted into the longitudinal slit during the installation stage, greatly facilitating the manufacture of the device.

[0046] The longitudinal slit also allows for visual detection of the position of a measurement cursor, which can be used as a visual indication of the relative position of the second shaft with respect to the first shaft.

[0047] Preferably, the measurement cursor comprises a copper layer fixed to the backside of the cursor, which copper layer amplifies the antenna gain and improves the sensitivity of the instrument, and is most preferably gold plated to avoid corrosion problems.

[0048] Preferably, the second shaft comprises a casing having a tubular body and a protruding portion extending beyond the diameter of the tubular body, the protruding portion housing an electronic board for powering and transmitting data to the sensor that is not aligned with the sensor strip, the electronic board being connected to the sensor strip via a flexible signal line.

[0049] Preferably, the data port may be provided in association with a mechanical torque transmission port provided for engaging a programmable tool with the external fixation post.

[0050] In a preferred embodiment, the external fixation support further comprises a rotatable adjustment mechanism for changing the length of the elongated body by moving a second shaft relative to the first shaft, and a second connection portion of the rotatable adjustment mechanism configured to releasably engage with a first connection portion of a programmable tool to enable torque transmission, wherein the port is defined by the second connection portion of the rotatable adjustment mechanism, and the second connection portion is in electrical communication with the first connection portion of the programmable tool when the first connection portion is engaged with the second connection portion, enabling data transmission from a sensor to the programmable tool.

[0051] The above-mentioned technical problem is also solved by a medical kit comprising both the above-described external fixator strut and a programmable tool operable to adjust the external fixator strut, wherein the programmable tool comprises: an output shaft; a motor operable to rotate the output shaft; a first coupling rigidly attached to the output shaft and configured to releasably engage with a corresponding second coupling of a rotatable adjustment mechanism of the external fixator strut, allowing torque transmission from the motor to the rotatable adjustment mechanism; a controller configured to drive the motor according to a prescription including instructions to adjust the external fixator strut; and a first coupling in electrical communication with the controller, configured to electrically connect with the second coupling of the rotatable adjustment mechanism when the first coupling engages with the second coupling, allowing data transmission from a sensor to the controller.

[0052] For a more complete understanding of the features and advantages of the present disclosure, reference is now made to the detailed description of four different support column embodiments of the present invention, taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0053] [Figure 1] FIG. 1 is a side view of a first embodiment of an external fixation 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 perspective view of a second embodiment of an external fixation post according to the present disclosure. [Figure 5] FIG. 5 is a detailed view of the perspective view of FIG. 4. [Figure 6] FIG. 5 is a cross-sectional view along the middle portion of the retractable tube of the external fixation strut of FIG. 4. [Figure 7] FIG. 10 is a side view of a third embodiment of an external fixator post according to the present disclosure. [Figure 8] FIG. 8 is a cross-sectional view of the external fixation strut taken along the cut plane indicated by CC in FIG. 7. [Figure 9] FIG. 1 is a perspective view of one embodiment of an external fixator post according to the present disclosure. [Figure 10] FIG. 10 is a side view of a fourth embodiment of an external fixator post according to the present disclosure. [Figure 11] FIG. 11 is a cross-sectional view of the external fixation strut along the cutting plane indicated by DD in FIG. 10. [Figure 12] FIG. 11 is a cross-sectional view of the external fixation post taken along the cut plane indicated by EE in FIG. 10. [Figure 13] FIG. 10 is a side view of a fourth embodiment of an external fixator post according to the present disclosure. [Figure 14] FIG. 11 is a cross-sectional view of the external fixation strut along the cut plane indicated by FF in FIG. 10. [Figure 15] FIG. 10 is a perspective view of a fourth embodiment of an external fixation post according to the present disclosure. [Figure 16] FIG. 15 is an enlarged detail view of the area indicated by G in FIG. [Figure 17] FIG. 15 is an enlarged detailed view of the area indicated by H in FIG. [Figure 18] FIG. 1 is a top view of one embodiment of a programmable tool according to the present disclosure. [Figure 19] FIG. 10 is a side view of an embodiment of an external fixator post adjacent to an embodiment of a programmable tool in accordance with the present disclosure. [Figure 20] 20 is a cross-sectional view of the external fixation post adjacent to the programmable tool along the section indicated by II in FIG. 19. [Figure 21] FIG. 10 is a side view of an embodiment of an external fixator post adjacent to an embodiment of a programmable tool in accordance with the present disclosure. [Figure 22] 22 is a cross-sectional view of the external fixation post adjacent to the programmable tool along the section indicated at JJ in FIG. 21. [Figure 23] FIG. 23 is an enlarged detailed view of the area indicated by K in FIG. 22. [Figure 24] 1 is a first half of a flowchart illustrating the operation of a programmable tool according to the present disclosure. [Figure 25] This is the second half of the flowchart in Figure 24. DETAILED DESCRIPTION OF THE INVENTION

[0054] While the making and using of various embodiments of the present disclosure are discussed in detail below, it should be understood that the present disclosure provides many applicable inventive concepts that can be embodied in a 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.

[0055] 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.

[0056] The rings of the external fixation device body, which can be fixed to each part of the bone via half pins or wires, are known per se and are not shown in the accompanying drawings.

[0057] 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 consists of a hollow body 2120 terminating in a first end 215 and a slider 2121 that slides within the body 2120 and receives the second tubular shaft 213.

[0058] 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.

[0059] In particular, the relationship between the body 2120 and the slider 2121, which defines the length of the first shaft 212, is changed in a first length adjustment 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.

[0060] Body 2120 and slider 2121 are locked together by a locking screw 2122 that is released upon manual adjustment of the relative positions of these two elements.

[0061] 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 included in the casing 217 of the slide 2121 of the first shaft 212. The rotatable adjustment mechanism will be described in more detail with reference to FIG.

[0062] The casing 217 has a tubular portion 217a that is slidable within the sleeve-like portion of the body 2120 and a protrusion 217b at its end that extends beyond the diameter of the tubular portion 217a. The rotatable adjustment mechanism 201 is housed within the protrusion 217b.

[0063] An external measurement cursor 219, firmly attached to the inner end of the second shaft 213 via legs that cross the longitudinal slit 220 of the slider 2121, slides along a scale 228 integral with the casing 217, thereby allowing the relative position of the second shaft 213 with respect to the first shaft 212 to be visually assessed.

[0064] The frame of the hollow body 2120 has an open side so that the scale 228 can be seen by a user. At one end of this open side, the frame has a transverse bridge 221. The bridge 221 is visible against the background of the scale 228, allowing the relative position of the slider 2121 with respect to the body 2120, and therefore the length of the first shaft 212, to be visually assessed.

[0065] FIG. 2 shows a cross-sectional view of the device of FIG.

[0066] 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.

[0067] Rotation imparted via the rotatable adjustment mechanism 201 defines a displacement 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.

[0068] In particular, the second shaft 213 has an externally threaded intermediate shank 2130 that is rotatably inserted within a sleeve 2160 at one end of each end 216 of the strut 200 and a slidable end piece 222 at the other end.

[0069] FIG. 3 shows a cross-sectional view of the rotatable adjustment mechanism 201 described above.

[0070] The rotatable adjustment mechanism 201 comprises a worm gear mechanism having a worm screw 2010 meshing with a worm gear 2011, which is coaxial with and threadedly engaged with the second shaft 213. Thus, rotation of the worm screw 2010 determines a corresponding rotation of the worm gear 2011, which in turn causes the second shaft 213 to translate relative to the first shaft 212.

[0071] The worm screw 2010 has a worm screw shaft 2012 that is perpendicular to the axis of the elongated body 211 .

[0072] A protruding head 2013 protruding from the side wall of the casing 217 rotatably receives the screw shaft 2010 and defines a second coupling portion 203 for attachment of a corresponding coupling portion of a wrench tool, as will be further described below.

[0073] 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 mounting a locking mechanism of an adjustment tool.

[0074] Details of the attachment are shown in Figure 9 and will be described with reference to an embodiment featuring the same attachment.

[0075] The position sensor 214 shown in Figure 2 above is provided in the first shaft 212 to sense the position of the measurement cursor 219. In this embodiment of the strut, the position sensor is based on inductive technology. It is glued to the outer surface. This sensor is also located inside the tubular element.

[0076] FIG. 4 shows an alternative embodiment of an external fixation post 200' that features an improved inductive position sensor 214'.

[0077] In such an alternative embodiment, the external fixation post 200' has substantially the same components and main features as the previously described embodiment, and therefore these components and features are indicated in the figures with the reference numbers already used and will not be described again in the following paragraphs.

[0078] The inductive position sensor 214' differs from the above-described position sensor 214 mainly in that the measurement cursor 219', the position of which is detected, is held inside the body of the first shaft 212, specifically inside the tubular element defined by the slide 2121.

[0079] The internal measurement cursor 219' is preferred as it does not interfere with the reading of the external scale and greatly reduces the risk of damage from handling.

[0080] On the other hand, the surrounding slide 2121 significantly interferes with reading the position of the internal measurement cursor 219', so the position sensor 214' needs to be precisely adjusted to cancel out the noise.

[0081] Figure 5 shows an enlarged detail view of the inductive position sensor 214' of Figure 4 described above. The internal measurement cursor 219' has a sled-like body with upper transverse grooves 2190 for receiving corresponding teeth on the bottom of the cylindrical slidable end piece 222 shown in Figure 6. The grooves and teeth interlock to define a connection for the measurement cursor 219' to interface with the end piece 222. The two elements may be glued or soldered together to ensure a more stable connection.

[0082] In another embodiment not shown in the accompanying drawings, the groove is not a through groove but is only present on the inner wall, so it is not visible from the outside. Holes can be added to the slider 2121 so that a cursor can be glued / welded.

[0083] The internal measurement cursor 219' further features a lateral protrusion 2191 that extends at least partially through the slit 220 and displays an index 2192 for visually reading the position of the element on the measurement scale below.

[0084] The internal measurement cursor 219' is fixed to the underside of the sled body and includes a gold-plated copper layer 2193 to prevent corrosion problems and to increase the antenna gain and improve the sensitivity of the instrument.

[0085] The inductive position sensor 214' further comprises a sensor strip 2142 obtained in a manner known per se.

[0086] FIG. 6 is a cross-sectional view of the external fixation post 200 ′ showing further details of the inductive position sensor 214 ′ and its sensor strip 2142 .

[0087] The sensor strip 2142 is mounted above an elongated support plate 2143 made of a ferromagnetic material (e.g., mu-metal). The ferrite plate 2143 serves to shield the sensor from external interference. The top surface of the sensor strip 2142 faces the internal measurement cursor 219', and the ferrite plate 2143 supports the sensor strip 2142 on its opposite side.

[0088] In manufacturing the device, the sensor strip 2142 can be adhered to the ferrite plate 2143 via a double-sided adhesive strip provided on the sensor strip 2142. The plate and strip combination is then inserted into the interior of the slider 2121 through the slit 220. Alternatively, a ferromagnetic plate is provided directly as the last layer of the sensor strip.

[0089] The position sensor 214' is preferably an absolute sensor.

[0090] FIG. 7 shows a schematic side view of a third embodiment of an external fixation strut 200″ according to the present invention.

[0091] The third embodiment is identical to the previous embodiments except for the position sensor 214'' which is based on capacitive technology.

[0092] FIG. 8 shows a cross-sectional view of the device of FIG.

[0093] A position sensor 214 ″ is glued to the inner surface of the slider 2121 and measures the relative position of the end piece 222 .

[0094] Thus, the position sensor 214 is housed within the casing 217 and is rigidly attached thereto, extending along the inner longitudinal length of the first shaft 212 .

[0095] The position sensor 214 detects the absolute position of the end piece 222 of the second shaft 213 and returns a measurement that can be used to assess the relative position of the second shaft 213 with respect to the first shaft 212 .

[0096] FIG. 9 shows a schematic perspective view of an external fixation strut 200″ according to a third embodiment of the invention, without further elements being disclosed.

[0097] 10 to 15 show a fourth embodiment of an external fixation strut 200''' having a shorter dimension compared to the long external fixation strut 200' according to the first embodiment described above.

[0098] In such an alternative embodiment, the external fixation strut 200''' has substantially the same components and major features as the longer embodiment described above. Therefore, these components and features are indicated in the figures with the reference numbers already used and will not be described again in the following paragraphs.

[0099] The main structural difference from the long version 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 attachment points defined by the ball joint 218 are located closer to each other.

[0100] FIG. 16 shows the construction details of the position sensor 214 introduced earlier.

[0101] The flexible signal line 2141 of the position sensor is made in the form of a flat cable and connects the electronic board 2140 to the body of the sensor 214 extending in the vicinity of the sensed end piece 222 .

[0102] The electronics board 2140 is intended to power and transfer data to the sensors and is intended to connect to the programmable tool 100 via a connection system described below.

[0103] 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 remainder of the shaft, and this curvature is designed to maintain an above threshold radius to prevent damage to the signal line during the manufacturing process.

[0104] The same structure of the electronic board 2140 with the flexible signal line 2141 is also suitably adopted in the position sensors 214', 214'' of the second and third embodiments.

[0105] FIG. 17 shows details of the construction of the end piece 222 introduced above.

[0106] As can be seen in the drawing, the end of the shank 2130 is rotatably inserted into the sleeve 2220 of the end piece 222 through an intervening ring 2221. The ring 2221 allows the end piece 222, and therefore the cursor 219, to move along the longitudinal axis of the strut 200''' while the shank 2130 rotates.

[0107] FIG. 18 is a top view of a programmable tool 100 according to the present disclosure in the form of a power wrench.

[0108] The wrench has a rigid outer casing 111 .

[0109] In the illustrated embodiment, the casing 111 has a generally cylindrical shape, but the shape of the housing 111 may be any shape and size that is convenient for use.

[0110] 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 .

[0111] The housing may include various connection ports, connectors, displays, and controllers.

[0112] In the illustrated embodiment, the interface portion includes first and second push buttons identified as Button 1 and Button 2, a display 116, and an annular LED indicator that can illuminate in various colors and in a steady or flashing mode to inform the user of several device states.

[0113] In a preferred embodiment, the circular LED indicator can have up to four illumination states, indicating user invocation of an action, a wrench operation in progress, and the success or failure of the wrench operation.

[0114] The LED indicators are preferably covered by a transparent light guide integrated into the casing 111 .

[0115] The device may further include a buzzer or other audio device.

[0116] The device further comprises a front muzzle 107 forward of the interface portion 113, which is arranged to connect to a torque input port of the rotatable adjustment mechanism 201 of the external fixation post 200, 200'.

[0117] FIG. 19 shows a side view of the programmable tool 100 being coupled to an external fixation post 200 .

[0118] FIG. 20 is a cross-sectional view of the two devices of FIG. 19, showing generally the main components inside the casing 111 of the programmable tool 100.

[0119] The programmable tool 100 comprises a power supply 106 in the form of a rechargeable battery, an electric motor 102 preferably with a gearbox in series with a coaxial output shaft 101, and a controller 104 in the form of a PCB.

[0120] The battery 106 is preferably charged wirelessly through inductive technology to minimize electrical hazards to the user.

[0121] The programmable tool 100 also includes 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 device that are adjusted by the tool 100.

[0122] The programmable tool 100 includes means for communicating with external data sources, such as a data port and / or a wireless connection. Preferably, the programmable tool has a SIM housing (not shown) for providing the device with internet connectivity.

[0123] The controller 104 of the programmable tool 100 is configured to communicate with an external portal directly or via a portable electronic device such as a smartphone to obtain a surgeon's prescription and update the status including at least the lengths of the multiple external fixation posts 200, 200', 200", 200"' of the external fixation device.

[0124] The controller 104 is connected to push buttons 114, 115, a display 116, and a circular LED indicator to read user commands, communicate status updates, or guide the user through the process of adjusting all the struts 200, 200', 200", 200"' according to a given recipe.

[0125] The muzzle 107 of the programmable tool 100 houses an output shaft 101 which terminates in a first connecting portion 103 in the shape of a wrench socket, in particular a hex socket.

[0126] The muzzle further includes a locking mechanism 109 operable to secure and selectively release the 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, as best seen in FIG.

[0127] The locking mechanism 109 is defined by the body of the muzzle 107, which can be drawn 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 23. The muzzle 107 includes an internal latch element 110, which can be in the form of a roller that moves along an oblique path, and which is externally biased by the action of the spring 1090 into engagement with the first coupling part 103.

[0128] A first connection portion 105 is provided around the first coupling portion 103, and this first connection portion 105 is electrically connected to the second connection portion 205 of the support columns 200, 200'.

[0129] When the locking mechanism 109 is engaged, the first connecting portion 105 is connected to the second connecting portion 205 of the post 200, 200', providing a data connection that allows the controller 104 to obtain data from the sensor 214.

[0130] The electrical connection also ensures power supply from the power source 106 to the sensor 214 .

[0131] FIG. 21 shows a further side view of the programmable tool 100 being coupled to the external fixation post 200 .

[0132] FIG. 22 is a cross-sectional view of the two devices of FIG.

[0133] FIG. 23 is an enlarged view of FIG. 19 showing the details of the first connection portion 105. As shown in FIG.

[0134] 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.

[0135] Additionally, the first connection portion 105 preferably comprises a plurality of outer connectors 1051 in the form of clips, tape springs or leaf spring connectors that protrude from the outer side of the annular recess 108. The outer connectors 1051 are for connecting to the second electrode.

[0136] In use, the inner connector 1050 contacts the inner surface 2050 of the outer sleeve of the protruding head 2013, and the outer connector 1051 contacts the outer surface 2051 of the outer sleeve. As best seen in Figure 12, the inner surface 2050 and the outer surface 2051 are separated by a dielectric layer 2052.

[0137] 24 and 25 show the first and second halves of a flow diagram of a method for operating the programmable tool 100. FIG.

[0138] The device can be switched from an OFF state 500 to an ON state 501 by the user, for example, by pressing Button 1 or Button 2 for a given time.

[0139] A similar user action may be required to switch the device to the off state 500.

[0140] After a given time has passed since being turned on, the device is associated with a particular case (502).

[0141] Then, after a command is entered by the user, the device connects to the Internet and retrieves the prescription for the patient's case from a dedicated portal (503).

[0142] After the prescription has been uploaded to the internal memory, the device goes into a general standby state (504) which may notify the user via the display 116 and / or the circular LED indicator.

[0143] Upon user command (eg, pressing button 1), the device will enter a waiting to connect state 505 and will signal via display 116 that it is ready to connect to a given pole.

[0144] In the waiting to connect state 505, the user is expected to mechanically connect the device to the mast 200, 200', which will again result in a data connection as described above.

[0145] Once the data connection has been made (507), the device suggests to the user that other posts 200, 200' may then be connected in a similar manner.

[0146] Once all the struts 200, 200' are properly docked, the device goes to the Wait to Dock state 508.

[0147] Thereafter, upon command by the user, the device goes into a wait state 509 in order to prepare to send a signal when a predetermined correction time 510 is reached. In this state, the user can query the device, for example by pressing button 1, which will display the next correction time (511).

[0148] When the correction time 510 is eventually reached, the user may be notified via an audible and / or visual signal that action is required.

[0149] The user will then be allowed to choose whether to proceed with the pole adjustment or postpone it 512. Button 1 and Button 2 may be used interchangeably to distinguish between the two options.

[0150] If the user decides to perform the adjustment, the device will guide the user to engage the struts 200, 200' to be adjusted (513). Once the struts 200, 200' are connected, the device will automatically perform the adjustment in an adjustment step 514 and then notify the user that the adjustment is complete (515).

[0151] If another support is to be adjusted, steps 513-515 are repeated, otherwise the user is notified that the correction is complete (516) and the process returns to the wait state 509.

[0152] The device may also update the prescription 517 from the wait state 509 whenever a prescription update is detected.

[0153] 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 the disclosure can be employed in various embodiments without departing from the scope of the disclosure. 。

[0154] 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. Such equivalents are considered to be within the scope of this disclosure and are covered by the claims.

[0155] The use of the word "a" or "an," when used in conjunction with the word "comprising" in the claims and / or specification, can mean "one," but is also consistent with the meanings of "one or more," "at least one," and "one or more than one." Although the present disclosure supports definitions that refer only to alternatives and "and / or," use of the term "or" in the claims is used to mean "and / or" unless explicitly indicated to refer only to alternatives or the alternatives are not mutually exclusive.

[0156] As used in this specification and the claims, 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.

Claims

1. An external fixator strut (200, 200', 200", 200"'), comprising: an elongated body (211) comprising at least a first shaft (212) and a second shaft (213) movable relative to each other to change the length of the elongated body (211); and at least one sensor (214, 214', 214") integrated into the external fixation strut (200, 200', 200", 200"') and configured to provide at least a measurement indicative of the length of the elongated body (211), The sensors (214, 214', 214") communicate with the programmable tool (100) via a data port engageable with the programmable tool (100) for lengthening / shortening the external fixator strut (200, 200', 200", 200'"), external fixator strut (200, 200', 200", 200'").

2. The external fixation strut (200, 200', 200''') according to claim 1, which uses either inductive or capacitive techniques to determine the position of the mobile element.

3. 3. The external fixation strut (200, 200', 200''') according to claim 2, wherein the movable element is an end piece (222) of the second shaft (213) and / or a measurement cursor (219, 219') that moves together with the end piece (222) relative to the second shaft (213).

4. The external fixation strut (200, 200', 200", 200''') according to claim 3, wherein said end piece (222) is slidable inside the tubular body (217a) of said first shaft (211).

5. The external fixation strut (200''') according to claim 4, wherein at least a majority of the measurement cursor (219') is housed inside the tubular body (217a) of the first shaft (211).

6. 6. The external fixation strut (200''') of claim 5, wherein the measurement cursor (219') is at least partially housed inside a longitudinal slit (220) of the tubular body (217a) of the first shaft (211), the longitudinal slit (220) extending in the longitudinal direction of the strut (200''').

7. 7. The external fixation strut (200''') according to claim 6, wherein the measurement cursor (219') engages with the end piece (222) via a groove and tooth structure extending laterally perpendicular to the longitudinal direction of the strut (200''') so that the measurement cursor (219') can be mounted by inserting the measurement cursor into the longitudinal slit (220).

8. The external fixation strut (200, 200', 200", 200''') of claim 4, wherein the sensor comprises a sensor strip (2142) located inside the tubular body (217a) of the first shaft (211).

9. The external fixation strut (200, 200', 200", 200''') of claim 8, wherein the sensor strip (2142) is a flexible printed circuit board and is attached on top of a rigid support plate (2143).

10. The external fixation strut (200, 200', 200", 200'") of claim 9, wherein the rigid support plate (2143) is made of a ferromagnetic material and at least partially shields the sensor strip (2142) from external noise.

11. An external fixation strut (200, 200', 200", 200'") as described in claim 10, wherein a longitudinal slit (220) is provided at least internally along the tubular body (217a) of the first shaft (211) so that the sensor strip (2142) and the rigid support plate (2143) can be inserted through the longitudinal slit (220) during the installation stage.

12. The external fixation column (200, 200', 200", 200'") of claim 9, wherein the second shaft (213) comprises a casing (217) having a tubular body (217a) and a protrusion (217b) extending beyond the diameter of the tubular body (217a), the protrusion (217b) accommodating an electronic board (2140) for sensor power supply and data transmission that is not aligned with the sensor strip (2143), and the electronic board (2140) is connected to the sensor strip (2142) through a flexible signal line (2141).

13. The external fixation strut (200, 200', 200", 200'") of claim 1, wherein the sensor (214, 214', 214") is powered through the port.

14. a rotatable adjustment mechanism (201) for moving the second shaft (213) relative to the first shaft (212) to change the length of the elongated body (211); and a second connection (203) of the rotatable adjustment mechanism (201) configured to releasably engage a first connection (103) of the programmable tool (100) to enable torque transmission, wherein the port is 2. The external fixation strut (200, 200', 200", 200'") of claim 1, defined by a second connection portion (205) that is in electrical communication with a first connection portion (105) of the programmable tool (100) when the first coupling portion (103) is engaged with the second coupling portion (203), enabling data transmission from the sensor (214, 214', 214") to the programmable tool (100).

15. 10. A medical kit comprising at least one external fixator post (200, 200', 200", 200''') according to claim 1 and a programmable tool (100) operable to adjust said external fixator post (200, 200', 200", 200'''), said programmable tool (100) comprising: an output shaft (101); a motor (102) operable to rotate said output shaft (101); a first coupling (103) rigidly attached to the output shaft (101) and configured to releasably engage a corresponding second coupling (203) of a rotatable adjustment mechanism (201) of the external fixation post (200, 200', 200", 200'"), allowing torque transmission from the motor (102) to the rotatable adjustment mechanism (201); a controller (104) configured to drive the motor (102) according to a prescription containing instructions for adjusting the external fixation post (200, 200', 200", 200'"); a first connection (105) in electrical communication with the controller (104) and configured to electrically connect to a second connection (205) of the rotatable adjustment mechanism (201) when the first connection (103) engages with the second connection (203), allowing data transmission from the sensors (214, 214', 214") to the controller (104); A medical kit comprising:

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