Tool for adjustment of an external fixation structure, adjustable external fixation structure and kit comprising such a

Abstract

The present disclosure relates to an external fixation strut (200 ') comprising: an elongate body (211) comprising at least a first shaft (212) and a second shaft (213), the first shaft and the second shaft being movable relative to each other to vary the length of the elongate body (211); at least a sensor (214 ') integrated in the outer stationary strut (200') and adapted to perform at least a measurement indicative of the length of the elongate body (211); wherein the sensor (214 ') is in communication with a programmable tool for extending / shortening the external fixation strut (200') through a data port engageable with the programmable tool.

Description

Technical Field

[0001] The present disclosure relates to the general field of external fixation, and more particularly, to the connection between an external fixator strut and a dedicated tool for incremental or decremental adjustment of such struts during pre-operative, intra-operative, and post-operative phases. Background Art

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

[0003] Generally, external fixation devices are commonly used in a variety of surgical procedures, including limb fracture fixation, lengthening, and deformity correction. The process involves the application of a rigid frame. This can be a circular system, such as a hexapod system and / or a circular system with multiple struts. Such systems typically include several rings or arches that are placed externally around the limb and attached to the bone segments using wires and half-pins inserted into the bone segments and connected to relevant sections of the external rigid frame. Additionally, unilateral systems, such as unilateral rails or unilateral monoliths, can be employed.

[0004] The rings of the rigid frame that are positioned relative to each other are interconnected directly or in combination with single-plane or multi-plane hinges by threaded and / or telescopic struts, which allows the relative positions of these rings to be adjusted longitudinally, rotationally, horizontally, or angularly with respect to each other over a period of time.

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

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

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

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

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

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

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

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

[0013] Adjustment of the strut lengths allows for drastic or gradual manipulation of the bone segments on several axes to simultaneously perform limb lengthening and correct angular, translational, and rotational deformities.

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

[0015] Since the prescription requires several adjustments over time, typically up to four adjustments per day, these regulations cannot be carried out by the surgeon or a dedicated practitioner most of the time. Therefore, the task of following the prescription is entrusted to one of the patient or their relatives, who perform it by turning the adjustment knob on the strut or by turning the nut of the threaded rod with a wrench.

[0016] This way of strut length adjustment is time-consuming (e.g., due to the loosening and re-tightening of the threaded rod nut before and after each adjustment), does not provide precise length adjustment (e.g., due to the difficulty in monitoring small amounts of adjustment), and generates overall frame instability during adjustment (e.g., due to the dimensional gaps between the connecting elements).

[0017] In addition, the prescription for length adjustment can be complex and is prone to human error during the process of complex prescriptions. Even if the patient is invited to verify the compliance between the prescription and the frame status by checking the strut length, the error is likely to remain unnoticed due to negligence in checking or its complete absence.

[0018] In addition, it must be considered that the feedback to the surgeon depends on the patient who is required to communicate the adjustments made on the struts, usually by uploading information on a dedicated portal. Again, the carelessness of the patient may result in incorrect or incomplete information being given to the surgeon.

[0019] It is easy to understand that errors in the execution of the prescription, especially if not quickly identified by the surgeon, may lead to an adverse effect on the final result of the correction process.

[0020] To mitigate the above drawbacks, in recent years, a programmable tool has been proposed for incrementally adjusting the length of an external fixator strut. For example, the tool described in the prior art application WO 2009 / 105479 in the name of Texas Scottish Rite Hospital for Children is designed as an electric wrench intended to engage the adjustment mechanism of an external fixator strut. The tool has an internal memory for storing the adjustment parameters of a prescription and is set to automatically adjust each strut according to the parameters.

[0021] Although the programmable tool offers many advantages over the prior art discussed previously, the programmable tool has remaining drawbacks, particularly regarding the ease of use of the device.

[0022] In fact, to correctly adjust the length parameter of the strut according to the memorized prescription, it is recommended to supply the tool with a real-time measurement of the strut length. If the tool implements the length increment or decrement according to the prescription without feedback, the adjustment process may easily become defective due to incremental errors, and any incorrect movement of the patient (e.g., connecting the tool to the wrong strut when applying the prescription) will likely disrupt the correct application of the adjustment plan over time.

[0023] Therefore, the programmable tool is preferably provided with a device for measuring the strut, such as a digital ruler intended to be connected to its opposite ends. However, such measurement devices increase the complexity of the device, and more importantly, they require the active action of the patient, thus making the process of applying the prescription more difficult and prone to human error.

[0024] It is emphasized that the technical problem of the present invention is to provide a new system for external fixation that solves or at least mitigates the drawbacks identified with respect to the prior art.

[0025] The main objective of the improved system of the present disclosure is to enhance the automation of the adjustment process without imposing an additional burden on the user (such as the identification of the number of struts and the external measurement of the strut length), while maintaining the high efficiency and cost-effectiveness of the system design. Summary of the Invention

[0026] The solution idea based on the present disclosure is: to provide an internal sensor within the external fixation strut to measure the length of the strut, and the sensor communicates directly with the programmable tool via a data port for extending / shortening the strut.

[0027] According to this solution idea, the potential technical problem of the present invention is solved by an external fixation strut that includes:

[0028] An elongate body comprising at least a first axis and a second axis, the first and second axes being movable relative to each other to change the length of the elongate body;

[0029] At least one sensor integrated in the external fixed strut and adapted to perform at least measurements indicating the length of the elongate body;

[0030] Wherein the sensor communicates with a programmable tool via a port engageable by the programmable tool.

[0031] In a preferred embodiment, the data port is also used to power the sensor.

[0032] This provides the advantage that the external fixed strut does not require an integrated power source (such as a battery): an external power source is sufficient to provide measurements when needed (i.e., during the operation of the programmable tool).

[0033] In a preferred embodiment, the sensor is an absolute sensor as opposed to a relative sensor, i.e., it returns the position in absolute terms rather than increments and decrements at each operation of the programmable tool.

[0034] Preferably, the sensor uses inductive or capacitive technology to determine the position of the movable element. The best mode of the present invention employs inductive technology.

[0035] The sensed movable element may be an end member of the second axis and / or a metering cursor that translates relative to the end member along with the second axis.

[0036] Preferably, the end member is slidable within the tubular body of the first axis. In particular, the end member may be a translatable nut rotatably connected to the inner free end of the threaded shank of the second axis.

[0037] In the case of a sensor using inductive technology, the sensed element is preferably a metering cursor attached to the end member.

[0038] In an embodiment, such a metering cursor is outside the tubular body of the first axis and projects from a longitudinal slit in the tubular body. This solution gives better sensitivity as the measurement is not affected by the surrounding tubular body.

[0039] In different embodiments, at least the main part of the metering cursor is accommodated within the tubular body of the first axis. Such an embodiment is preferred as the internal metering cursor is less prone to breakage and does not obstruct the visual reading of external indices even if fine tuning of the sensor is required to eliminate noise caused by the surrounding body.

[0040] Preferably, the metering cursor is at least partially accommodated within a longitudinal slot in the tubular body of the first axis, the longitudinal slot extending in the longitudinal direction of the strut.

[0041] Preferably, the metering cursor engages with the end member via a groove and a tooth structure that extends in a transverse direction orthogonal to the longitudinal direction of the strut, such that the metering cursor can be installed by inserting it through the longitudinal slit.

[0042] This solution is particularly convenient because it simplifies the manufacture of the externally fixed strut.

[0043] Preferably, the sensor includes a sensing strip disposed within the tubular body of the first shaft.

[0044] If present, the metering cursor slides on the sensing strip.

[0045] Preferably, the sensing strip is a flexible printed circuit board that is attached on top of a rigid support plate.

[0046] The use of the rigid support plate simplifies the manufacture of the device because the sensing strip can be attached to the plate before being inserted into the tubular body.

[0047] Preferably, the rigid support plate is made of a ferromagnetic material (such as ferrite). This protects the sensing strip from external noise interference at least partially.

[0048] As described above, preferably, a longitudinal slit is provided along the tubular body of the first shaft. In this way, the sensing strip and the rigid support plate can be inserted through the longitudinal slit during the installation phase, making it easier to manufacture the device.

[0049] The longitudinal slit also makes it possible to visually detect the position of the metering cursor, which can be used as a visual marker for the relative position of the second shaft with respect to the first shaft.

[0050] Preferably, the metering cursor includes a copper layer fixed to the lower side of the cursor. The copper layer is intended to amplify the antenna gain, thereby increasing the sensitivity of the metering device. The copper layer is most preferably gold-plated to avoid corrosion problems.

[0051] Preferably, the second shaft includes a housing having a tubular body and a protrusion that extends beyond the diameter of the cover tubular body. The protrusion houses an electronic board for power supply and data transmission of the sensor. The electronic board is not aligned with the sensing strip, and the electronic board is connected to the sensing strip through a flexible signal line.

[0052] Preferably, the data port can be provided in combination with a mechanical torque transmission port that is provided for engaging a programmable tool to the externally fixed strut.

[0053] In a preferred embodiment, the external fixation strut further comprises: a rotatable adjustment mechanism for moving the second shaft relative to the first shaft, thereby changing the length of the elongated body; and a second coupling portion of the rotatable adjustment mechanism, the second coupling portion being adapted to releasably engage with a first coupling portion of the programmable tool to effect torque transmission; wherein the port is defined by a second connection portion of the rotatable adjustment mechanism, and when the first coupling portion engages the second coupling portion, the second connection portion is in electrical communication with a first connection portion of the programmable tool and enables data to be transmitted from the sensor to the programmable tool.

[0054] The above technical problem is also solved by a medical kit comprising both the external fixation strut discussed previously and a programmable tool operable to adjust the external fixation strut, and the medical kit comprises:

[0055] An output shaft;

[0056] A motor operable to rotate the output shaft;

[0057] A first coupling portion rigidly attached to the output shaft and adapted to releasably engage with a corresponding second coupling portion of the rotatable adjustment mechanism of the external fixation strut, thereby enabling torque to be transmitted from the motor to the rotatable adjustment mechanism;

[0058] A controller configured to drive the motor according to a prescription, the prescription including instructions for adjusting the external fixation strut;

[0059] A first connection portion in electrical communication with the controller and adapted to be electrically connected to a second connection portion of the rotatable adjustment mechanism when the first coupling portion engages the second coupling portion, thereby enabling data to be transmitted from the sensor to the controller. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] To more fully understand the features and advantages of the present disclosure, reference is now made to the detailed description of four different strut embodiments of the present invention and the accompanying drawings, wherein:

[0061] Figure 1 is a side view of a first embodiment of an external fixation strut according to the present disclosure;

[0062] Figure 2 is Figure 1 a cross-sectional view of the external fixation strut taken along the cutting plane indicated by A-A in

[0063] Figure 3 is Figure 1 a cross-sectional view of the external fixation strut taken along the cutting plane indicated by B-B in

[0064] Figure 4Is a perspective view of a second embodiment of an external fixing strut according to the present disclosure;

[0065] Figure 5 Is Figure 4 Details of the perspective view;

[0066] Figure 6 Is a cross-sectional view of the external fixing strut taken along the middle section of the extractable tube; Figure 4 Of the external fixing strut;

[0067] Figure 7 Is a side view of a third embodiment of an external fixing strut according to the present disclosure;

[0068] Figure 8 Is along Figure 7 A cross-sectional view of the external fixing strut taken along the cutting plane indicated by C-C in;

[0069] Figure 9 Is a perspective view of an embodiment of an external fixing strut according to the present disclosure;

[0070] Figure 10 Is a side view of a fourth embodiment of an external fixing strut according to the present disclosure;

[0071] Figure 11 Is along Figure 10 A cross-sectional view of the external fixing strut taken along the cutting plane indicated by D-D in;

[0072] Figure 12 Is along Figure 10 A cross-sectional view of the external fixing strut taken along the cutting plane indicated by E-E in;

[0073] Figure 13 Is a side view of a fourth embodiment of an external fixing strut according to the present disclosure;

[0074] Figure 14 Is along Figure 10 A cross-sectional view of the external fixing strut taken along the cutting plane indicated by F-F in;

[0075] Figure 15 Is a perspective view of a fourth embodiment of an external fixing strut according to the present disclosure;

[0076] Figure 16 Is at Figure 14 Enlarged details of the area indicated by G in;

[0077] Figure 17 Is at Figure 14 Enlarged details of the area indicated by H in;

[0078] Figure 18 Is a top view of an embodiment of a programmable tool according to the present disclosure;

[0079] Figure 19 is a side view of an embodiment of an external fixing strut adjacent to an embodiment of a programmable tool according to the present disclosure;

[0080] Figure 20 is along Figure 19 a cross-sectional view of an external fixing strut adjacent to a programmable tool taken along the cutting plane indicated by I-I in

[0081] Figure 21 is a side view of an embodiment of an external fixing strut adjacent to an embodiment of a programmable tool according to the present disclosure;

[0082] Figure 22 is along Figure 21 a cross-sectional view of an external fixing strut adjacent to a programmable tool taken along the cutting plane indicated by J-J in

[0083] Figure 23 is Figure 22 an enlarged detail of the area indicated by K in

[0084] Figure 24 is the top portion of a flow chart showing the operation of a programmable tool according to the present disclosure;

[0085] Figure 25 is Figure 24 the bottom portion of the flow chart of DETAILED DESCRIPTION

[0086] Although 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 wide variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways of making and using the present disclosure and do not delimit the scope of the present disclosure.

[0087] Figure 1 Shows a schematic side view of an improved external fixing strut 200 according to the present invention, the improved external fixing strut having an elongate body 211 having opposite ends 215, 216 configured to be attached to respective fixing rings or arches of an external fixing device (preferably a hexapod type).

[0088] The rings of the body of an external fixator that can be fixed to a bone site via half pins or wires are known and not depicted in the drawings.

[0089] The elongated body 211 is formed by a first hollow tubular shaft 212, and a second tubular shaft 213 is slidably received in the first hollow tubular shaft. The first shaft 212 in turn consists of a hollow body 2120 and a sliding body 2121. The body 2120 has a first end 215 as its vertex, and the sliding body 2121 slides within the body 2120 and houses the second tubular shaft 213.

[0090] The relationship between the two bodies of the first shaft 212 and between the first shaft and the second shaft 213 imparts an overall telescopic configuration to the strut 200, such that the length of the elongated body 211 can be adjusted according to the need to hold the rings to be interconnected in a predetermined relative spatial relationship.

[0091] In particular, the relationship between the body 2120 and the sliding body 2121 (which defines the length of the first shaft 212) varies in a first adjustment of the length between these two attachment points of the strut 200, while the relationship between the first shaft 212 and the second shaft 213 varies to finely adjust the strut length, especially during post-operative follow-up.

[0092] The body 2120 and the sliding body 2121 are locked together by a locking screw 2122, which is released for manually adjusting the relative position of the two elements.

[0093] Conversely, the position of the second shaft 213 relative to the first shaft 212 is adjusted by a rotatable adjustment mechanism 201 housed in a housing 217 of the sliding body 2121 of the first shaft 212. Reference will be made Figure 3 to describe the rotatable adjustment mechanism in more detail.

[0094] The housing 217 has a tubular portion 217a and a protruding portion 217b. The tubular portion 217a is capable of sliding within a sleeve portion of the body 2120, and the protruding portion 217b extends beyond the diameter of the tubular portion 217a at its end. The rotatable adjustment mechanism 201 is conveniently housed in the protruding portion 217b.

[0095] An external metering cursor 219, which is firmly attached to the outside of the inner end of the second shaft 213 by legs crossing a longitudinal slit 220 of the sliding body 2121, slides along a scale 228 integral with the housing 217, and makes it possible to visually evaluate the relative position of the second shaft 213 relative to the first shaft 212.

[0096] To make the scale 228 visible to the user, the frame of the hollow body 2120 has an open side. A transverse bridging member 221 of the frame is provided at the end of this open side. The bridging member 221 is visible against the background of the scale 228, such that the relative position of the sliding body 2121 relative to the body 2120, i.e., the length of the first shaft 212, can be visually evaluated.

[0097] Figure 2 shows Figure 1 a cross-sectional view of the device of

[0098] At both ends 215, 216 of the strut 200, ball joints 218 are provided, which make it possible to articulate the strut 200 relative to the fixed ring or arch to which it is attached.

[0099] The rotation given by the rotatable adjustment mechanism 201 defines the displacement of the second shaft 213 relative to the first shaft 212 through a threaded connection, such that the second end 216 is pulled away from the first end 215 or dragged towards the first end.

[0100] In particular, the second shaft 213 has an intermediate handle 2130 with an external threaded connection. The intermediate handle 2130 is rotatably inserted into the sleeve 2160 of the corresponding end 216 of the strut 200 on one side and rotatably inserted into the slidable end member 222 on the other side.

[0101] Figure 3 A cross-sectional view of the above-mentioned rotatable adjustment mechanism 201 is shown.

[0102] The rotatable adjustment mechanism 201 includes a worm gear mechanism having a worm 2010 meshing with a worm wheel 2011, which is coaxial with the second shaft 213 and threadedly engages with the second shaft. Thus, the rotation of the worm 2010 determines the corresponding rotation of the worm wheel 2011, which in turn drives the second shaft 213 to translate relative to the first shaft 212.

[0103] The worm 2010 has a worm shaft 2012 orthogonal to the axis of the elongated body 211.

[0104] The protruding head 2013 protruding from the side wall of the housing 217 rotatably houses the screw 2010, and as will be discussed further below, the protruding head defines a second coupling portion 203 for the attachment of a corresponding coupling portion for a wrench tool.

[0105] The protruding head 2013 further defines an outer sleeve surrounding the second coupling portion 203. In the depicted embodiment, the outer sleeve has an inner circular profile and an outer hexagonal profile, and the outer hexagonal profile includes an external groove 210 for a locking mechanism for attaching an adjustment tool.

[0106] Reference will be made to Figure 9 the embodiment depicted in

[0107] and having the same attachment portions to discuss further details of the attachment. Figure 2is visible) is disposed within the first shaft 212 to sense the position of the metering cursor 219. In this embodiment of the strut, the position sensor is based on inductive technology. The position sensor is glued on the outer surface. The sensor is also positioned within the tubular element.

[0108] Figure 4 Relates to an alternative embodiment of the external fixed strut 200', which is characterized by an improved version of the inductive position sensor 214'.

[0109] In this alternative embodiment, the external fixed strut 200' substantially has the same components and main features as the previously described previous embodiment. Therefore, these components and features are represented in the figures by the previously used reference numerals, and these components and features will not be described again in the following paragraphs.

[0110] The inductive position sensor 214' is mainly different from the previously described position sensor 214 in that the metering cursor 219' (whose position is detected) is held within the body of the first shaft 212: specifically, held within the tubular element defined by the sliding body 2121.

[0111] The internal metering cursor 219' is preferred because it does not interfere with the reading on the external scale and it greatly reduces the risk of damage from handling.

[0112] On the other hand, the surrounding sliding body 2121 seriously interferes with the reading of the position of the internal metering cursor 219', and the position sensor 214' needs to be precisely tuned to eliminate noise.

[0113] Figure 5 Shows an enlarged detail of the inductive position sensor 214' from the previous Figure 4 The internal metering cursor 219' has a sled-shaped body, characterized by upper transverse grooves 2190 for inserting into corresponding teeth provided at the bottom of the further cylindrical slidable end member 222, which is visible in Figure 6 The grooves and teeth engage to define a connection such that the metering cursor 219' moves with the end member 222. To ensure a more stable connection, these two elements can also be glued or welded.

[0114] In an alternative embodiment not visible in the drawings, the grooves may not be through grooves existing only on the inner wall. Therefore, the grooves are not visible from the outside. Holes can be added to the sliding body 2121 to allow bonding / welding of the cursor. The internal metering cursor 219' is further characterized by lateral protrusions 2191 that at least partially extend through the slit 220 and exhibit an index 2192 for visually reading the position of the element on the underlying metering scale.

[0115] The internal metering cursor 219' includes a copper layer 2193, gold-plated to avoid corrosion problems, which is fixed on the lower side of the sled-shaped body. The copper layer 2193 is designed to amplify the antenna gain, thereby increasing the sensitivity of the metering device.

[0116] The inductive position sensor 214' further includes a sensing strip 2142, which is obtained as a flexible printed circuit board in a manner known per se.

[0117] Figure 6 A cross-section of the external fixing strut 200' is shown, showing further details of the inductive position sensor 214' and its sensing strip 2142.

[0118] The sensing strip 2142 is attached to an elongated support plate 2143 made of a ferromagnetic material (e.g., a high-permeability metal). The ferrite plate 2143 is designed to protect the sensor from external interference. The top surface of the sensing strip 2142 faces the internal metering cursor 219', and the ferrite plate 2143 faces away from the sensing strip 2142 on the other side.

[0119] In the manufacture of the device, the sensing strip 2142 can be glued to the ferrite plate 2143 via a double-sided adhesive strip provided on the sensing strip 2142. Then, the combined plate and strip are inserted into the sliding body 2121 through a slit 220. Alternatively, the ferromagnetic plate is directly provided as the last layer of the sensing strip.

[0120] The position sensor 214' is preferably an absolute sensor.

[0121] Figure 7 A schematic side view of a third embodiment of the external fixing strut 200" according to the present invention is shown.

[0122] The third embodiment is the same as the previous embodiment, except for the position sensor 214" based on capacitance technology.

[0123] Figure 8 Shown is Figure 7 a cross-sectional view of the device.

[0124] The position sensor 214" is glued to the inner surface of the sliding body 2121, and it measures the relative position of the end member 222.

[0125] The position sensor 214 is thus accommodated within the housing 217, firmly attached to the housing, and extends along the longitudinal internal length of the first shaft 212.

[0126] The position sensor 214 detects the absolute position of the end member 222 of the second shaft 213 and returns a measurement value, which can be used to evaluate the relative position of the second shaft 213 with respect to the first shaft 212.

[0127] Figure 9 Figure 1 shows a schematic perspective view of the external fixing strut 200" according to the third embodiment of the present invention, without showing additional elements.

[0128] Figures 10 - 15 Reference is made to a fourth embodiment of the external fixing strut 200”', which is shorter in size compared to the long external fixing strut 200' according to the first embodiment discussed previously.

[0129] In this alternative embodiment, the external fixing strut 200”' generally has the same components and main features as the previously described longer embodiment. Therefore, these components and features are denoted by the same reference numerals used previously in the figures and will not be described again in the following paragraphs.

[0130] The main structural difference with respect to the longer form is that the two attachment points defined by the ball joint 218 are set closer to each other here, due to the fact that the ball joint of the first shaft 212 is not placed at its end 215, but at the opposite end of the hollow body 2120 of the first shaft 215.

[0131] Figure 16 Figure 2 shows details of the configuration of the position sensor 214 introduced previously.

[0132] The flexible signal line 2141 of the position sensor (formed in the form of a flat cable) connects the electronic board 2140 to the body of the sensor 214, which extends near the sensed end member 222.

[0133] The electronic board 2140 is intended for sensor power supply and data transmission and is intended to be connected to the programmable tool 100 via the connection system described below.

[0134] It can be seen that the flexible signal line 2141 has at least one curvature to connect the housing of the rotation adjustment mechanism to the remaining part of the shaft. This curvature is designed such that the radius remains above a threshold value to avoid damaging the signal line during the manufacturing process.

[0135] In the position sensors 214' and 214" of the second and third embodiments, the same construction of the electronic board 2140 with the flexible signal line 2141 is also preferably employed.

[0136] Figure 17 Figure 3 shows details of the construction of the end member 222 introduced previously.

[0137] As can be seen in the figure, the end of the handle 2130 is rotatably inserted through the insertion ring 2221 into the sleeve 2220 of the end member 222. The ring 2221 allows the end member 222 and thus allows the cursor 219 to translate along the longitudinal axis of the support 200''' when the handle 2130 rotates.

[0138] Figure 18 A top view of a programmable tool 100 according to the present disclosure is shown, which is in the form of an electric wrench.

[0139] The wrench includes a rigid outer housing 111.

[0140] In the depicted embodiment, the housing 111 has a substantially cylindrical shape. However, the shape of the outer housing 111 can be any shape and size convenient for use.

[0141] In the depicted embodiment, the housing 111 defines a hand-held portion having a distal grip 112 with an ergonomic handle, followed by a proximal interface portion 113.

[0142] The outer housing can have various connection ports, connectors, displays, and controllers.

[0143] In the depicted embodiment, the interface portion includes a first button and a second button (identified as Button 1 and Button 2) and a display 116, and further has a ring-shaped LED indicator that can be illuminated in different colors and in a steady or pulsed mode to signal multiple device states to the user.

[0144] In a preferred embodiment, the ring-shaped LED indicator can have up to four illuminated states, signaling respectively: a user's action call, an ongoing operation of the wrench, a successful or unsuccessful completion of the wrench operation.

[0145] The LED indicator is preferably covered by a transparent light guide integrated into the housing 111.

[0146] The device can further include a buzzer or any other audio device.

[0147] The device further includes a front muzzle 107 located before the interface portion 113, which is arranged to be connected to the torque input port of a rotatable adjustment mechanism 201 of an external fixed support 200, 200'.

[0148] Figure 19 A side view of the programmable tool 100 to be coupled to an external fixed support 200 is shown.

[0149] Figure 20 is Figure 19Cross-sectional views of two devices and schematically show the main components inside the housing 111 of the programmable tool 100.

[0150] The programmable tool 100 includes a power source 106 in the form of a rechargeable battery, an electric motor 102, and a controller 104 in the form of a PCB. The electric motor preferably includes a gearbox collinear with the coaxial output shaft 101.

[0151] The battery 106 is preferably recharged wirelessly by induction technology to minimize the electrical hazard to the user.

[0152] The programmable tool 100 may further include an internal memory, which can be conveniently used to store the patient's prescription and the actual lengths of the plurality of struts that make up the external fixator to be adjusted by the tool 100.

[0153] The programmable tool 100 has means for communicating with an external data source in the form of a data port and / or a wireless connection. Preferably, the programmable tool is a SIM housing (not shown), which is designed to provide an Internet connection to the device.

[0154] The controller 104 of the programmable tool 100 is adapted to communicate with an external entry directly or via a portable electronic device (such as a smart phone) to retrieve the surgeon's prescription and update the status of at least the lengths of a number of external fixing struts 200, 200', 200", 200'" of the external fixator.

[0155] The controller 104 is connected to buttons 114, 115, a display 116, and a ring LED indicator to read the user's commands, communication status updates, or guide the user throughout the process of adjusting all the struts 200, 200', 200", 200'" according to a given prescription.

[0156] The muzzle 107 of the programmable tool 100 houses the output shaft 101, which culminates in a first coupling portion 103 in the form of a wrench socket, particularly a hexagon socket.

[0157] The muzzle further includes a locking mechanism 109, which is operable to fix and selectively release the engagement of the first coupling portion 103 with the second coupling portion 203. When the locking mechanism 109 is engaged, the protruding head 2013 of the rotatable adjustment mechanism 201 is received within the annular recess 108 of the muzzle 107, as best shown in Figure 23 shown.

[0158] 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 it against an elastic device, which can be in Figure 23The form of spring 1090 best shown in. The muzzle 107 has a latch element 110 inside, which can be in the form of a roller moving along an inclined path, and the roller is biased outward under the action of spring 1090 to engage the first coupling part 103.

[0159] A first connection part 105 is provided around the first coupling part 103, and this first connection part is intended to be electrically connected to the second connection part 205 of the struts 200, 200'.

[0160] When the locking mechanism 109 is engaged, the first connection part 105 is connected to the second connection part 205 of the struts 200, 200', and a data connection is provided, which allows the controller 104 to retrieve data from the sensor 214.

[0161] The electrical connection further ensures power supply to the sensor 214 from the power source 106.

[0162] Figure 21 Another side view of the programmable tool 100 to be coupled to the external fixed strut 200 is shown.

[0163] Figure 22 is Figure 18 A cross-sectional view of two devices of.

[0164] Figure 23 is Figure 19 An enlarged view of, showing the details of the first connection part 105.

[0165] The first connection part 105 includes a plurality of inner connectors 1050 at the bottom of the annular recess 108. The inner connectors are preferably in the form of spring pins and are intended to connect the first electrode.

[0166] Furthermore, the first connection part 105 includes a plurality of outer connectors 1051. The outer connectors are preferably in the form of clips, strip springs or leaf spring connectors and project from the outer surface of the annular recess 108. The outer connector 1051 is intended to connect the second electrode.

[0167] In use, the inner connector 1050 contacts the inner surface 2050 of the outer tube of the protruding head 2013, while the outer connector 1051 contacts the outer surface 2051 of the same tube. As best seen in Figure 12 The inner surface 2050 and the outer surface 2051 are separated by a dielectric layer 2052.

[0168] Figure 24 and Figure 25 Show the top and bottom, showing a flowchart of the operation method of the programmable tool 100.

[0169] The user can switch the device from the off state 500 to the on state 501, for example, by pressing button 1 or button 2 for a given time.

[0170] A similar user action can be required to return the device to the off state 500.

[0171] After being on for a given time, the device will be associated with a specific case 502.

[0172] Then, upon the user's command, the device will connect to the Internet and retrieve a prescription for the patient's case from a dedicated portal 503.

[0173] After the prescription has been uploaded to the internal memory, the device is in a general waiting state 504, which can be signaled to the user via the display 116 and / or the ring LED indicator.

[0174] When the user commands (e.g., presses button 1), the device is in a connection waiting state 505 and it will signal via the display 116 that it is ready to connect to a given support.

[0175] In the connection waiting state 505, it is expected that the user mechanically connects the device to the supports 200, 200', which also results in a data connection as previously discussed.

[0176] When the data connection 507 is performed, the device notifies the user, who can then connect the other supports 200, 200' in a similar manner.

[0177] Once all the supports 200, 200' have been correctly connected, the device enters a connection waiting state 508.

[0178] Then, upon the user's command, the device enters an idle state 509, ready to signal when the specified calibration time 510 is reached. In this state, the user can query the device - for example, by pressing button 1 - which will then display the next calibration time 511.

[0179] When the calibration time 510 is finally reached, the user can be notified via an audio and / or visual signal that he / she needs to take action.

[0180] The user will then be presented with the option to perform or postpone 512 the support adjustment. Buttons 1 and 2 can be used alternately to distinguish between the two options.

[0181] If the user decides to perform the calibration, the device will then guide the user towards engaging the supports 200, 200' to be adjusted 513. Once the supports 200, 200' are connected, the device will automatically perform the adjustment in the adjustment step 514 and will then signal the user that the adjustment is complete 515.

[0182] If another strut is to be adjusted, repeat steps 513-515; otherwise, the device signals completion of calibration 516 to the user and returns to the idle state 509.

[0183] From the idle state 509, whenever a prescription update is detected, the device is also capable of updating the prescription 517.

[0184] It will be understood that the specific embodiments described herein are shown by way of illustration and not limitation of the disclosure. The main features of the disclosure may be employed in different 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, many equivalents to the specific apparatus and procedures described herein. Such equivalents are considered to be within the scope of the disclosure and are covered by the claims.

[0185] All publications and patent applications mentioned in this specification indicate the level of skill of those skilled in the art to which the disclosure pertains. All publications and patent applications are incorporated herein by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0186] When the term “comprising” is used in the claims and / or the specification, the use of the word “a” or “an” may mean “one,” but it is also consistent with the meaning 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 only alternative or the alternatives are mutually exclusive, although the disclosure supports definitions that refer to only alternatives and “and / or.”

[0187] 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 fixing strut (200, 200', 200", 200'''), comprising: An elongated body (211), the elongated body comprising at least a first axis (212) and a second axis (213), the first axis and the second axis being movable relative to each other to change the length of the elongated body (211); At least sensors (214, 214', 214"), the sensors being integrated in the external fixing strut (200, 200', 200", 200''') and adapted to at least perform measurements indicating the length of the elongated body (211); Wherein the sensors (214, 214', 214") communicate with a programmable tool (100) for extending / shortening the external fixing strut (200, 200', 200", 200''') through a data port that can be engaged by the programmable tool (100).

2. The external fixing strut (200, 200', 200", 200''') according to claim 1, wherein, The sensors (214, 214', 214") use inductive technology or capacitive technology to determine the position of a movable element.

3. The external fixing strut (200, 200', 200''') according to claim 2, wherein, The movable element is an end member (222) of the second axis (213) and / or a measuring cursor (219, 219'), the measuring cursor translating relative to the second axis (213) together with the end member (222).

4. The external fixing strut (200, 200', 200''') according to claim 3, wherein, The end member (222) is capable of sliding within the tubular body (217a) of the first axis (211).

5. The external fixing strut (200"') according to claim 4, wherein, At least a major part of the measuring cursor (219') is received within the tubular body (217a) of the first axis (211).

6. The external fixing strut (200''') according to claim 5, wherein, The measuring cursor (219') is at least partially received within a longitudinal slot (220) of the tubular body (217a) of the first axis (211), the longitudinal slot (220) extending in the longitudinal direction of the strut (200''').

7. The external fixing strut (200"') according to claim 6, wherein, The measuring cursor (219') is engaged with the end member (222) via a groove and tooth structure that extends in a transverse direction orthogonal to the longitudinal direction of the strut (200'''), such that the measuring cursor (219') can be installed by inserting the measuring cursor through the longitudinal slot (220).

8. The external fixing strut (200, 200', 200", 200"') according to claim 4, wherein, The sensor comprises a sensing strip (2142) disposed within the tubular body (217a) of the first axis (211).

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

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

11. The external fixing strut (200, 200', 200", 200"') according to claim 10, wherein, A longitudinal slot (220) is provided at least internally along the tubular body (217a) of the first axis (211) such that the sensing strip (2142) and the rigid support plate (2143) can be inserted through the longitudinal slot (220) during the installation phase.

12. The external fixing strut (200, 200', 200", 200''') according to claim 9, wherein, The second shaft (213) includes a housing (217) having a tubular body (217a) and a protrusion (217b) that extends beyond the diameter of the tubular body (217a). The protrusion (217b) houses an electronic board (2140) for sensor power supply and data transmission. The electronic board is not aligned with the sensing strip (2143), and the electronic board (2140) is connected to the sensing strip (2142) by a flexible signal line (2141).

13. The external fixing strut (200, 200', 200", 200''') according to claim 1, wherein, The sensors (214, 214', 214") are powered through the port.

14. The external fixing strut (200, 200', 200", 200''') according to claim 1, further comprising: A rotatable 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); and a second coupling portion (203) of the rotatable adjustment mechanism (201) adapted to releasably engage with a first coupling portion (103) of the programmable tool (100) for torque transmission; wherein the port is defined by a second connection portion (205) of the rotatable adjustment mechanism (201), and when the first coupling portion (103) engages the second coupling portion (203), the second connection portion is in electrical communication with a first connection portion (105) of the programmable tool (100) and enables data to be transmitted from the sensors (214, 214', 214") to the programmable tool (100).

15. A medical kit comprising at least one external fixation strut (200, 200', 200", 200''') according to claim 1 and a programmable tool (100) operable to adjust the external fixation strut (200, 200', 200", 200'''), and the medical kit includes: An output shaft (101); A motor (102) operable to rotate the output shaft (101); A first coupling portion (103) firmly attached to the output shaft (101) and adapted to releasably engage with a corresponding second coupling portion (203) of a rotatable adjustment mechanism (201) of the external fixation strut (200, 200', 200", 200''') so as to enable torque to be transmitted from the motor (102) to the rotatable adjustment mechanism (201); A controller (104) configured to drive the motor (102) according to a prescription including instructions for adjusting the external fixation strut (200, 200', 200", 200'''). A first connection part (105), the first connection part being in electrical communication with the controller (104) and being adapted to be electrically connected to a second connection part (205) of the rotatable adjustment mechanism (201) when the first connection part (103) is engaged with the second connection part (203), so that data can be transmitted from the sensors (214, 214', 214") to the controller (104).

Images