Wrench for adjusting external fixed strut, adjustable external fixed strut and kit comprising said fixed strut and said wrench
By integrating mechanical and electrical connectors in a programmable wrench, combined with sensor feedback control, the problem of operation complexity and high error rate of external fixed strut adjustment tools is solved, and accurate and automated strut length adjustment is achieved.
Patent Information
- Application Number
- CN202380077664.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-01-09
- Filing Date
- 2023-11-16
- Publication Date
- 2025-07-04
AI Technical Summary
Existing external fixed strut adjustment tools have problems such as complex operation, error prone and difficult to achieve precise length adjustment, especially in wireless communication and real-time measurement.
A programmable wrench is designed with integrated mechanical and electrical connectors in a common port for releasable engagement with external fixed struts for torque and data transmission, and is equipped with sensors for length measurement and feedback control to ensure correct strut adjustment.
It improves the automation of the adjustment process, reduces user operation complexity, reduces the incidence of errors, and achieves accurate support length adjustment and real-time monitoring.
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Figure CN120265225A_ABST
Abstract
Description
Technical Field
[0001] The present disclosure relates to the general field of external fixation devices and, more particularly, to a wrench for adjusting an external fixation rod, an adjustable external fixation rod, and a kit including the fixation rod and the wrench. Background Art
[0002] Without limiting the scope of the present disclosure, the background of the present disclosure is described herein in connection with external fixation devices and related tools for adjusting rods or other connecting rods.
[0003] Generally, external fixation devices are commonly used in various surgical procedures, including limb fracture fixation, limb 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 having multiple rods. Such systems typically include multiple rings or arches that are placed around the limb externally and attached to the bone segments by using Kirschner wires and half-pins that are inserted into the bone segments and connected to relevant parts of the external rigid frame. Additionally, a unilateral system, such as a unilateral rail or a unilateral monomer, can also be employed.
[0004] The rings that are opposite to each other in the rigid frame are directly connected by threads and / or telescopic rods or connected by incorporating single-plane or multi-plane hinges, which allows for the adjustment of the relative positions of the rings longitudinally, rotationally, horizontally, or angularly over a period of time.
[0005] For example, in limb lengthening, the bone is surgically divided into two segments, and then Kirschner wires and half-pins are inserted into the bone segments above and below the surgical bone incision and attached to the rings of a rigid frame that are interconnected by rods or telescopic connecting rods.
[0006] For limb lengthening, the opposite rings are preferably directly interconnected by at least three to four threaded or telescopic rods, the lengths of which are regularly adjusted and allow the bone segments to be gradually separated longitudinally.
[0007] The rigid frame is used to gradually push the two bone segments longitudinally apart over a period of time (e.g., one millimeter per day). This allows new bone to gradually form in the bone segment gap generated by this traction technique. Once the desired lengthening amount (e.g., 5 - 6 cm) is reached, 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 pathological nature and / or lengthening amount).
[0008] Similarly, in deformity correction, the bone (usually at the apex of the deformity) is surgically divided into two segments, and Kirschner wires and half-pins are inserted into the bone segments above and below the surgical bone incision 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 rods to which hinges and angular distractors are attached, and the angular distractor is 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 external fixator. When the Ilizarov external fixator is used for limb lengthening or deformity correction, it consists of multiple rings or arches that are placed externally around the limb and attached to the surgically separated bone segments using Kirschner wires and half-pins. For angular deformity correction, the opposing rings of the Ilizarov external fixator are connected by a pair of hinges and an angular distractor, the pair of hinges providing a rotational axis for the bone segments, and the angular distractor gradually pushing the two rings and the 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 external fixator.
[0011] The Taylor Spatial Frame includes two external fixation rings that are attached to the bone ends by Kirschner wires and half-pins and connected together by five or six telescoping rods that have multi-planar hinges located at the ends of the rods. Each rod 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 such fixation devices are commercially known as TrueLok and Sheffield.
[0013] Adjustment of the strut lengths allows for acute or progressive manipulation of the bone segments on multiple axes to simultaneously perform limb lengthening and correct angular, translational, and rotational deformities.
[0014] The daily adjustment amount of the strut lengths is typically calculated by dedicated software. Once the device is attached to the bone segments, a large number of 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 the rings. After calculating the total amount of adjustment for each strut length, the software provides a tabular description ("prescription") of the amount of adjustment for each strut length that each increment should achieve, including the number identifying the individual rod, the amount of adjustment required, and the time when this adjustment is planned. In most cases of deformity correction, the rods are adjusted in different directions (shortening / lengthening) and by different amounts.
[0015] Since the prescription needs to be adjusted several times over time, often up to four times a day, in most cases these regulations cannot be carried out by the surgeon or a specialist doctor. Therefore, the task of following the prescription is entrusted to one of the patient or their relatives, who do this by turning the adjustment knob on the strut or turning the nut of the threaded rod with a wrench.
[0016] This way of adjusting the strut length is time-consuming (e.g., due to loosening and re-tightening the threaded rod nut before and after each adjustment), does not provide precise length adjustment (e.g., due to the difficulty of monitoring small adjustments), and causes instability of the overall frame during adjustment (e.g., due to dimensional clearances between the connecting elements).
[0017] In addition, the prescription for length adjustment can be complex, and human errors are likely to occur during the execution of complex prescriptions. Even if the patient is required to verify the compliance between the prescription and the frame state by checking the strut length, the error is likely to be overlooked due to negligence or complete lack of checking.
[0018] In addition, it must be taken into account that the feedback to the surgeon depends on the patient, who usually needs to convey the adjustments made to the strut by uploading information to a dedicated portal. Similarly, the carelessness of the patient may also result in incorrect or incomplete information being provided to the surgeon.
[0019] It is not difficult to understand that errors that occur during the execution of the prescription, especially if not detected in time by the surgeon, may have an adverse effect on the final result of the correction process.
[0020] To mitigate the above drawbacks, a programmable tool has been proposed in recent years for gradually adjusting the length of the struts of an external fixator. For example, the tool described in the prior art application WO2009 / 105479 filed in the name of Texas Scottish Rite Hospital for Children is designed as an electric wrench that is used to engage with the adjustment mechanism of the external fixation strut. The tool has an internal memory for storing the adjustment parameters of the prescription and is set to automatically adjust each strut according to the parameters.
[0021] Although the programmable tool has many advantages compared to the prior art discussed before, it still has some drawbacks, especially in terms of the ease of use of the device.
[0022] In fact, in order to correctly adjust the length parameter of the strut according to the stored prescription, it is desirable to provide the tool with a real-time measurement of the strut length. If the tool performs length increments or decrements according to the prescription without feedback, then the adjustment process is easily flawed due to cumulative errors, and any incorrect action by the patient (such as coupling the tool to the wrong strut during prescription execution) can disrupt the correct application of the adjustment plan over time.
[0023] Accordingly, the programmable tool is preferably equipped with means for measuring the strut length, such as digital rulers for coupling to its opposite ends. However, such measuring means increase the complexity of the device, and more importantly, they require active operation by the patient, thus making the process of executing the prescription more difficult and more prone to human error.
[0024] It has been observed that alternative methods for measuring the strut length (such as by sensors mounted on the strut itself) have been ruled out so far due to the difficulty of powering the internal sensors and transmitting the sensor signals to the tool. In particular, due to practical design and regulatory compliance, wireless methods are difficult to implement, while adding a wired plug seems impractical both in terms of product design and usability.
[0025] In addition, the programmable tool preferably requires further interface means, such as means for identifying the individual struts, to assist the patient in correctly executing the prescription. For example, such means can be an RFID reader that is used to read a unique identification code from the strut. However, this increases the complexity and leaves a certain degree of uncertainty in the process, as the patient may erroneously omit the step of identifying the strut or, after correctly identifying the strut, erroneously apply the prescribed length increment or decrement to an adjacent strut.
[0026] Therefore, according to the known solutions, the interaction between the adjustment tool, the strut to be adjusted, and the patient is very cumbersome and can lead to operating errors. Accordingly, there is a desire to provide a system for adjusting an externally fixed strut that solves or at least mitigates the disadvantages present in the prior art.
[0027] The technical problem to be solved by the present invention is to provide a new system for adjusting an externally fixed strut that solves or at least mitigates the disadvantages present in the prior art.
[0028] A main object of the improved system of the present disclosure is to enhance the degree of automation of the adjustment process without imposing additional task burdens on the user, such as strut number identification and external measurement of the strut length, and without the need for wireless data communication between the adjustment tool and the strut.
[0029] Another objective of the improved system is to provide better interaction with the external fixed strut, enabling its efficient operation while automating / securing the adjustment process and avoiding adjustment errors.
[0030] Another objective of the improved system is to maintain a lean and cost-effective design. Summary of the Invention
[0031] The solution concept on which the present disclosure is based is to integrate at least one data port within the mechanical interface between the programmable tool and the strut. Thus, this data port can be used to transfer the readings of internal sensors to the controller that drives the programmable tool.
[0032] According to such a solution concept, the technical problem of the present invention can be solved by a programmable wrench for automatically adjusting the length of an external fixed strut, the programmable wrench comprising:
[0033] A mechanical connector for releasably engaging with the external fixed strut, thereby enabling the transfer of at least the adjustment torque from the programmable wrench to the external fixed strut;
[0034] An electrical connector for releasably connecting with the external fixed strut, thereby enabling at least data transfer from the external fixed strut to the programmable wrench;
[0035] Wherein, the mechanical connector and the electrical connector are integrated in a common port and jointly engage with and disengage from the external fixed strut.
[0036] By installing one or more sensors (especially position sensors for length measurement) in the strut, data transfer can be conveniently carried out.
[0037] Therefore, a controller provided in the programmable wrench or configured to communicate with the programmable wrench is configured to obtain at least one measurement value indicating the length of the external fixed strut through the port.
[0038] The controller can also be configured to perform feedback control using the measurement value indicating the length of the external fixed strut when driving the motor according to a prescription.
[0039] In addition, the controller can use this measurement value to update the status of the strut, and this status can be sent to the surgeon, thereby enabling monitoring of the application of the prescription.
[0040] In addition, the strut can be equipped with a read-only memory that contains, for example, a unique code for identifying the strut during the entire length adjustment operation. By obtaining the identification code through the provided data transfer, the controller of the programmable tool can automatically check whether the tool is coupled to the correct strut and prohibit operation in case of incorrect connection.
[0041] In one embodiment, the controller can even obtain and apply the correct increments / decrements from the prescription in view of the identified strut.
[0042] Preferably, the programmable wrench further includes a power source, and the electrical connection between the first connection portion and the second connection portion further enables power transmission to the external fixed strut. In other words, the electrical connector further enables power transmission from the programmable wrench to the external fixed strut.
[0043] Therefore, the electrical interface has the dual functions of powering the sensor and data communication.
[0044] In a preferred embodiment, the common port is a wrench socket. For example, the wrench socket can be a hexagon socket, and the corresponding top end of the external fixed strut can be a hexagon key.
[0045] Preferably, an external engagement surface is provided externally relative to the first and second coupling portions to transmit the resisting reaction torque while the driving torque is transmitted from the wrench to the external fixed strut.
[0046] Preferably, the electrical connector defines a wired contact with the external fixed strut, with the first pole connected through an internal connector and the second pole connected through an external connector.
[0047] In a preferred embodiment, the internal connector is a pogo-pin and the external connector is a metal spring.
[0048] The above technical problem is also solved by an external fixed strut, which includes:
[0049] An elongated body, the length of which can be adjusted by a rotatable adjustment mechanism;
[0050] A mechanical connector of the adjustment mechanism, which is used for releasably engaging with the programmable wrench, so as to realize at least the transmission of the adjustment torque from the programmable wrench to the external fixed strut;
[0051] An electrical connector, which is used for releasably connecting with the programmable wrench, so as to realize data and / or power transmission between the external fixed strut and the programmable wrench;
[0052] Wherein, the mechanical connector and the electrical connector are integrated in a common port and jointly engage and disengage with the programmable wrench.
[0053] The above technical problem is also solved by an external fixed strut, which includes:
[0054] An elongated body, which has a variable length;
[0055] At least one sensor, which is embedded in the elongate body and is capable of detecting at least a change in the length of the elongate body.
[0056] Preferably, the external fixing strut according to the present invention further comprises at least one wired data port, which can be engaged with a programmable wrench for automatically adjusting the length of the external fixing strut so as to transmit data regarding the change in the length of the elongate body to the programmable wrench.
[0057] In a preferred embodiment, the sensor is a position sensor that detects the position of a first axis of the elongate body relative to a second axis, the first axis and the second axis being telescopically connected to define the elongate body.
[0058] Preferably, the sensor is an inductive or capacitive sensor.
[0059] Preferably, the sensor detects the position of a metering cursor along a sensing strip, the metering cursor being integral with one of the first axis or the second axis, and the sensing strip being integral with the other of the first axis or the second axis.
[0060] The above technical problem is also solved by a programmable wrench for automatically adjusting the length of an external fixing strut of an external fixing system, wherein the programmable wrench is adapted to:
[0061] - Obtain prescription data, which is related to a determined patient case and includes instructions for performing the adjustment of the external fixing strut of the patient;
[0062] - Guide the user to adjust the external fixing strut according to the prescription data;
[0063] - Update the state of the external fixing system according to the readings of the length sensors embedded in each external fixing strut.
[0064] The step of guiding the user to adjust the external fixing strut may include at least one sub-step, namely indicating to the user which external fixing strut needs to be adjusted.
[0065] During the step of guiding the user to adjust the external fixing strut, the direction and time at which the wrench can be activated are automatically calculated according to the currently connected strut and the updated prescription data.
[0066] Preferably, the activation time is feedback-controlled according to the readings of the length sensors of the engaged external fixing strut.
[0067] Preferably, the programmable wrench includes a port for connecting to the external fixing strut, and the programmable wrench can clearly identify the external fixing strut to which it is connected through the port.
[0068] Preferably, the prescription data includes a schedule for adjusting the length of the external fixation strut, and the programmable wrench is configured to alert the user each time a length adjustment of the external fixation strut is scheduled.
[0069] Several embodiments of the wrench, strut, and system of the present invention will be described below with reference to the accompanying drawings, so as to embody the features and advantages of the wrench, strut, and system of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS
[0070] To more fully understand the features and advantages of the present disclosure, four different strut embodiments of the present invention will now be described in detail in conjunction with the accompanying drawings, wherein:
[0071] Figure 1 is a side view of a first embodiment of an external fixation strut according to the present disclosure;
[0072] Figure 2 is along Figure 1 a cross-sectional view of the external fixation strut taken along the cutting plane indicated by A-A in
[0073] Figure 3 is along Figure 1 a cross-sectional view of the external fixation strut taken along the cutting plane indicated by B-B in
[0074] Figure 4 is a perspective view of a second embodiment of an external fixation strut according to the present disclosure;
[0075] Figure 5 is Figure 4 a detailed view of the perspective view of
[0076] Figure 6 is Figure 4 a cross-sectional view of the external fixation strut of
[0077] Figure 7 is a side view of a third embodiment of an external fixation strut according to the present disclosure;
[0078] Figure 8 is along Figure 7 a cross-sectional view of the external fixation strut taken along the cutting plane indicated by C-C in
[0079] Figure 9 is a perspective view of an embodiment of an external fixation strut according to the present disclosure;
[0080] Figure 10 is a side view of a fourth embodiment of an external fixation strut according to the present disclosure;
[0081] Figure 11 is along Figure 10Cross-sectional view of the external fixing strut taken along the cutting plane denoted by D-D;
[0082] Figure 12 is along Figure 10 Cross-sectional view of the external fixing strut taken along the cutting plane denoted by E-E;
[0083] Figure 13 Side view of the fourth embodiment of the external fixing strut according to the present disclosure;
[0084] Figure 14 is along Figure 10 Cross-sectional view of the external fixing strut taken along the cutting plane denoted by F-F;
[0085] Figure 15 Isometric view of the fourth embodiment of the external fixing strut according to the present disclosure;
[0086] Figure 16 is Figure 14 Enlarged detail view of the area denoted by G;
[0087] Figure 17 is Figure 14 Enlarged detail view of the area denoted by H;
[0088] Figure 18 Top view of an embodiment of a programmable tool according to the present disclosure;
[0089] Figure 19 Side view of an adjacent part of an embodiment of an external fixing strut and an embodiment of a programmable tool according to the present disclosure;
[0090] Figure 20 is along Figure 19 Cross-sectional view of the adjacent part of the external fixing strut and the programmable tool taken along the cutting plane denoted by I-I;
[0091] Figure 21 Side view of an adjacent part of an embodiment of an external fixing strut and an embodiment of a programmable tool according to the present disclosure;
[0092] Figure 22 is along Figure 21 Cross-sectional view of the adjacent part of the external fixing strut and the programmable tool taken along the cutting plane denoted by J-J;
[0093] Figure 23 is Figure 22 Enlarged detail view of the area denoted by K;
[0094] Figure 24 General schematic diagram of a medical component according to the present disclosure, wherein the tool interacts with the external unit and the external fixing strut;
[0095] Figure 25 is a block diagram of an exemplary architecture and connections according to an embodiment of the present disclosure;
[0096] Figures 26A to 26W shows an example of an interface displayed on a display of a tool according to an embodiment of the present disclosure;
[0097] Figure 27 is the upper half of a flowchart showing the operation of a tool according to an embodiment of the present disclosure; and
[0098] Figure 28 is Figure 27 the lower half of the flowchart of. Detailed Description of the Invention
[0099] 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 situations. The specific embodiments discussed herein merely illustrate specific ways of making and using the present disclosure and do not limit the scope of the present disclosure.
[0100] Referring to the above figures, a tool 100 for adjusting an external fixing strut according to the present disclosure is generally schematically represented by 100, and different embodiments of the external fixing strut are generally schematically represented by 200, 200', 200'', 200'''.
[0101] It should be noted that these figures are schematic diagrams, not drawn to scale, but are drawn to emphasize the important features of the present invention. In addition, different elements are depicted schematically in the figures, and their shapes vary depending on the required application. It should also be noted that in the figures, the same reference numerals refer to elements having the same shape or function. Finally, the specific features described for one embodiment in the figures are also applicable to other embodiments shown in other figures.
[0102] Obviously, as is well known to those skilled in the art, certain technical details of the present invention can be replaced by other technically equivalent details without departing from the scope of the claimed protection.
[0103] In addition, when illustrating the order of process steps, it is not necessary to follow the marked order, and unless otherwise clearly stated, the steps can be reversed.
[0104] The programmable tool 100 of the present disclosure is adapted to adjust the external fixing struts 200, 200', 200'', 200''' by enhanced interaction with the external fixing struts 200, 200', 200'', 200''' and by communicating with an external unit (such as a cloud unit and / or a user device), which will be disclosed below.
[0105] Figure 1 Figure 1 shows a schematic side view of an improved external fixation strut 200 according to the present disclosure, the external fixation strut 200 having an elongated body 211 having opposite ends 215, 216 configured to be attached to respective fixing rings or arches of an external fixator of a preferably hexapod type.
[0106] The rings of the body of the external fixator can be fixed to the bone site by half pins or Kirschner wires, which rings themselves are known and not shown in the drawings.
[0107] The elongated body 211 is formed by a first hollow tubular shaft 212 in which a second tubular shaft 213 is slidably received. The first shaft 212 in turn consists of a hollow body 2120 with a first end 215 and a sliding body 2121 that slides within the body 2120 and houses the second tubular shaft 213.
[0108] 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 elongated body 201 can be adjusted in length according to the need to maintain the interconnected rings in a predetermined relative spatial relationship.
[0109] In particular, when making a first adjustment to the length between the two attachment points of the strut 200, the relationship between the body 2120 and the sliding body 2121 (which defines the length of the first shaft 212) is changed, while changing the relationship between the first shaft 212 and the second shaft 213 is for fine adjustment of the length of the strut, particularly during postoperative follow-up.
[0110] The body 2120 and the sliding body 2121 are locked together by a locking screw 2122, and loosening this locking screw 2122 allows manual adjustment of the relative position of the two elements.
[0111] Conversely, the position of the second shaft 213 relative to the first shaft 212 is adjusted by a rotatable adjustment mechanism 201 contained in a housing 217 of the sliding body 2121 of the first shaft 212. The rotatable adjustment mechanism will be described in more detail with reference to Figure 3 The rotatable adjustment mechanism will be described in more detail.
[0112] An external metering cursor 219, which is firmly attached to the inner end of the second shaft 213 by legs passing through longitudinal slots 220 in the sliding body 2121, slides along a scale 228 integral with the housing 217, thereby enabling a visual assessment of the relative position of the second shaft 213 relative to the first shaft 212.
[0113] To make the scale 228 visible to the user, the frame of the hollow body 2120 has an open side. The transverse bridge 221 of the frame is provided at one end of the open side. The transverse bridge 221 is visible against the background of the scale 228, enabling a visual assessment of the relative position of the sliding body 2121 with respect to the body 2120, i.e., the length of the first axis 212.
[0114] Figure 2 A cross-sectional view of the device is shown. Figure 1 is shown.
[0115] Ball-and-socket joints 218 are provided at the two ends 215, 216 of the strut 200, which enables the strut 200 to be articulated relative to the fixed ring or arch to which it is attached.
[0116] The rotation applied through the rotatable adjustment mechanism 201 defines the displacement of the second axis 213 relative to the first axis 212 through a threaded connection, thereby pulling the second end 216 away from or towards the first end 215.
[0117] In particular, the second axis 213 has an intermediate handle 2130, which is externally threaded. The intermediate handle 2130 is rotatably inserted into the sleeve 2160 at the corresponding end 216 of the strut 200 on one side and into the slidable end piece 222 on the other side.
[0118] Figure 3 A cross-sectional view of the above-described rotatable adjustment mechanism 201 is shown.
[0119] The rotatable adjustment mechanism 201 includes a worm gear mechanism having a worm 2010 meshing with a worm wheel 2011, and the worm wheel 2011 is coaxial with and threadedly engaged with the second axis 213. Thus, the rotation of the worm 2010 causes a corresponding rotation of the worm wheel 2011, and the worm wheel 2011 in turn drives the second axis 213 to translate relative to the first axis 212.
[0120] The worm 2010 has a worm shaft 2012, which is orthogonal to the axis of the elongated body 211.
[0121] The protruding head 2013 protruding from the side wall of the housing 217 rotatably accommodates the screw shaft 2010 and defines a second coupling portion 203 for attaching a corresponding coupling portion of a wrench tool as will be further discussed below.
[0122] The protruding head 2013 further defines an outer sleeve surrounding the second coupling portion 203. In the illustrated embodiment, the outer sleeve has an internal circular profile and an external hexagonal profile, and the external hexagonal profile includes an external groove 210 for attaching a locking mechanism of an adjustment tool.
[0123] Further details of the attachment will be discussed with reference to Figure 9 the embodiment shown and having the same attachment part feature.
[0124] In the previously discussed Figure 2 the position sensor 214 visible in is arranged 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 adhered to the outer surface. The sensor is also positioned within the tubular element.
[0125] Figure 4 An alternative embodiment relates to an externally fixed strut 200’ having the feature of an improved version of the inductive position sensor 214’.
[0126] In this alternative embodiment, the externally fixed strut 200’ substantially has the same components and main features as the previously described previous embodiment. Accordingly, these components and features are denoted in the figures by the previously used reference numerals and will not be re-described in the following paragraphs.
[0127] The main difference between the inductive position sensor 214’ and the previously described position sensor 214 is that the metering cursor 219’ at the position to be detected is held within the body of the first shaft 212: in particular, within the tubular element defined by the sliding body 2121.
[0128] 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 due to operation.
[0129] On the other hand, the surrounding sliding body 2121 seriously interferes with the reading of the position of the internal metering cursor 219’ and precise tuning of the position sensor 214’ is required to eliminate noise.
[0130] Figure 5 An enlarged detail view of the inductive position sensor 214’ in the previously Figure 4 is shown. The internal metering cursor 219’ has a sled-shaped body characterized by having upper transverse grooves 2190 for inserting into corresponding teeth provided at the bottom of the cylindrical slidable end piece 222 (visible in Figure 6 )). The grooves and the teeth engage with each other to define a connection such that the metering cursor 219’ moves together with the end piece 222. To ensure a more stable connection, the two elements can also be glued or brazed.
[0131] In an alternative embodiment not shown in the drawings, the groove may not be a through-groove and only exist on the inner wall. Therefore, the groove is not visible from the outside. Holes can be added to the sliding body 2121 to allow the bonding / welding of the cursor. The internal metering cursor 219' also has a side protrusion 2191 that at least partially extends through the slit 220, and the side protrusion 2191 has a scale index 2192 for visually reading the element position on the underlying metering scale.
[0132] The internal metering cursor 219' includes a copper layer 2193 that is gold-plated to avoid corrosion problems, and the copper layer 2193 is fixed to the lower side of the sled-shaped body. The copper layer 2193 is used to amplify the antenna gain, thereby improving the sensitivity of the metering device.
[0133] The inductive position sensor 214' also includes a sensing strip 2142 that is obtained as a flexible printed circuit board in a manner known per se.
[0134] Figure 6 A cross-section of the external fixed strut 200' is shown, in which further details of the inductive position sensor 214' and its sensing strip 2142 are shown.
[0135] The sensing strip 2142 is attached above an elongated support plate 2143 made of a ferromagnetic material (such as Mu metal). The ferrite plate 2143 is used 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 supports the sensing strip 2142 on the other side.
[0136] During the device manufacturing process, the sensing strip 2142 can be bonded to the ferrite plate 2143 through 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 the slit 220. As an alternative, the ferromagnetic plate is directly provided as the last layer of the sensing strip.
[0137] The position sensor 214' is preferably an absolute sensor.
[0138] Figure 7 A schematic side view of a third embodiment of the external fixed strut 200'' according to the present invention is shown.
[0139] The third embodiment is the same as the previous embodiment except for the position sensor 214'' based on capacitance technology.
[0140] Figure 8 Shows Figure 7 a cross-sectional view of the device.
[0141] The "position sensor 214" is bonded to the inner surface of the sliding body 2121, and the measuring end 222 of the position sensor 214 measures the relative position.
[0142] Therefore, the position sensor 214" is housed within the housing 217, firmly attached to the housing 217, and the position sensor 214" extends along the longitudinal inner length of the first shaft 212.
[0143] The position sensor 214" detects the absolute position of the end 222 of the second shaft 213 and returns a measured value that can be used to evaluate the relative position of the second shaft 213 relative to the first shaft 212.
[0144] Figure 9 A schematic perspective view of the external fixing strut 200" according to the third embodiment of the present invention is shown, in which no additional elements are disclosed.
[0145] Figures 10 to 15 Relates to a fourth embodiment of the external fixing strut 200"', which is shorter in size relative to the long external fixing strut 200' according to the first embodiment discussed previously.
[0146] In this alternative embodiment, the external fixing strut 200"' substantially has the same components and main features as the previously described longer embodiment. Accordingly, these components and features are denoted in the figures by the previously used reference numerals and will not be described again in the following paragraphs.
[0147] The main structural difference relative to the longer version is that here, the two attachment points defined by the ball-and-socket joint 218 are set closer to each other because of the fact that the ball-and-socket 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.
[0148] Figure 16 The construction details of the previously introduced position sensor 214 are shown.
[0149] The flexible signal line 2141 of the position sensor made in the form of a flat cable connects the electronic board 2140 to the body of the sensor, which extends near the sensed end 222.
[0150] The electronic board 2140 is used to power the sensor and transmit data, and is used to connect to the programmable tool 100 through the connection system described below.
[0151] It can be seen that the flexible signal line 2141 has at least one curvature to connect the housing of the rotatable adjustment mechanism to the rest of the shaft. The curvature is designed such that the radius remains above a threshold to avoid damaging the signal line during the manufacturing process.
[0152] The same configuration of the electronic board 2140 with the flexible signal line 2141 is also preferably adopted in the position sensors 214' and 214" of the second and third embodiments.
[0153] Figure 17 The construction details of the previously introduced end piece 222 are shown.
[0154] As shown, the end of the handle 2130 is rotatably inserted into the sleeve 2220 of the end piece 222 through an interposed ring 2221. When the handle 2130 rotates, the ring 2221 allows the end piece 222 and the cursor 219 to translate along the longitudinal axis of the support 200'".
[0155] Figure 18 A top view of a programmable tool 100 according to the present disclosure is shown. The tool is in the form of a wrench, particularly an electronic wrench.
[0156] The wrench includes a rigid outer housing 111.
[0157] In the illustrated embodiment, the housing 111 has a substantially cylindrical shape. However, the shape of the housing 111 can be any shape and size that facilitates use.
[0158] In the illustrated embodiment, the housing 111 defines a hand-held member having a distal grip portion 112 with an ergonomic handle, followed by a proximal interface portion 113.
[0159] The housing can have various connection ports, connectors, displays, and controllers.
[0160] In particular, in the illustrated exemplary embodiment, the interface portion includes a first button 114 and a second button 115 (also identified herein as button 1 and button 2), a display 116, and also has an indicator 120, such as an annular LED indicator (e.g., including an RGB LED), which can be lit in various colors and in a steady or pulsed mode to signal the user about multiple device operation states.
[0161] In a preferred embodiment, the annular LED indicator can have up to four lit states, signaling respectively: the user needs to take action, the operation the wrench is performing, the successful or unsuccessful completion of the wrench operation. In one embodiment, there may be another state of the LED indicator, which, for example, indicates a charging operation.
[0162] The LED indicator can also be covered by a transparent light guide integrated into the housing 111.
[0163] The device may further include a buzzer or any other audio device. Additionally, the device may further include a wireless charging device and a Near Field Communication (NFC) device for communicating with other electronic devices, which will be described in detail below.
[0164] The device further includes a front muzzle 107 located in front of the interface portion 113, and the front muzzle 107 is arranged to be connected to the torque input port of the rotatable adjustment mechanism 201 of the external fixed struts 200, 200', 200'', 200'''.
[0165] Figure 19 A side view of the programmable tool 100 about to be coupled to the external fixed strut 200 is shown.
[0166] Figure 20 is Figure 19 A cross-sectional view of two devices and schematically shows the main components within the housing 111 of the programmable tool 100.
[0167] The programmable tool 100 includes: a power source 106 in the form of a rechargeable battery; a motor 102, which preferably includes a gearbox arranged in a straight line with a coaxial output shaft 101; and a controller 104, such as in the form of a PCB. The controller 104 is adapted to manage the operation of the tool 100 and is not limited by a specific configuration.
[0168] The battery 106 is preferably wirelessly charged by inductive technology to minimize electrical hazards to the user. Accordingly, a device for wireless charging can be provided.
[0169] 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 multiple struts constituting the external fixator to be adjusted by the tool 100. In any case, the present disclosure is not limited by the architecture of the tool memory, which may be a component of the controller 104 or a separate memory portion operably connected to the controller 104.
[0170] The programmable tool 100 further includes a device (referred to herein as "TX") for data communication with an external unit, particularly with an external data source, such as in the form of a data port and / or a wireless connection. Preferably, the programmable tool has a SIM card housing (not shown), which is used to provide an Internet connection for the device, even though any other suitable device can be used for this purpose. Such a device TX may further include a Bluetooth connection port or a Wi-Fi connection port, as well as the aforementioned NFC device, for example, for connecting to a user device or other external devices.
[0171] The controller 104 of the programmable tool 100 is adapted to communicate with an external portal directly or via a portable electronic device such as a smart phone to obtain a surgeon's prescription and update the status of at least the lengths of a plurality of external fixation struts 200, 200', 200", 200'" including an external fixator.
[0172] The controller 104 is connected to buttons 114, 115, a display 116, and an annular LED indicator to read user instructions, convey status updates, or guide the user throughout the adjustment of all struts 200, 200', 200", 200'" according to a given prescription.
[0173] The front-end interface 107 of the programmable tool 100 houses an output shaft 101 that terminates in a first coupling portion 103 in the form of a wrench socket (specifically a hexagon socket).
[0174] The front-end interface further includes a locking mechanism 109 that is operable to fix and selectively release the engagement of the first coupling portion 103 with the second coupling portion 203. When the locking mechanism 109 is engaged, the protruding head 2013 of the rotatable adjustment mechanism 201 is received within an annular recess 108 of the front-end interface 107, as Figure 23 shown.
[0175] The locking mechanism 109 is defined by the body of the front-end interface 107. By pressing the front-end interface 107 against an elastic device, the front-end interface 107 can be retracted towards the housing 111 of the programmable tool 100, and the elastic device can be in the form of a spring 1090 (as Figure 23 best shown). The front-end interface 107 has a latch element 110 internally, and the latch element 110 can be in the form of a roller that moves along an inclined path and is externally biased by the spring 1090 to engage the first coupling portion 103.
[0176] A first connection portion 105 is provided around the first coupling portion 103 for electrical connection to the second connection portion 205 of the struts 200, 200', 200", 200'".
[0177] When the locking mechanism 109 is engaged, the first connection portion 105 is connected to the second connection portion 205 of the struts 200, 200', 200", 200'", and provides a data connection that allows the controller 104 to obtain data from the sensor 214.
[0178] The electrical connection further ensures that the sensor 214 is powered by the power supply 106.
[0179] Figure 21Shows another side view of the programmable tool 100 about to be coupled to the external fixed strut 200.
[0180] Figure 22 is Figure 18 A cross-sectional view of two devices of.
[0181] Figure 23 is Figure 19 An enlarged view of, which shows the details of the first connection part 105.
[0182] The first connection part 105 includes a plurality of internal connectors 1050 located at the bottom of the annular recess 108. These internal connectors 1050 are preferably in the form of spring pins for connecting the first electrode.
[0183] In addition, the first connection part 105 includes a plurality of external connectors 1051. The plurality of external connectors 1051 are preferably in the form of clamps, spring-loaded or leaf spring connectors and protrude from the outer surface of the annular recess 108. The external connectors 1051 are used to connect the second electrode.
[0184] In use, the internal connectors 1050 contact the inner surface 2050 of the outer sleeve of the protruding head 2013, while the external connectors 1051 contact the outer surface 2051 of the same sleeve. As Figure 12 Best shown, the inner surface 2050 and the outer surface 2051 are separated by a dielectric layer 2052.
[0185] To improve the interaction between the tool 100 and the external fixed strut 200, advantageously according to the present disclosure, the controller 104 includes a set of instructions that, when executed, cause the tool 100 to automatically perform the operations disclosed below.
[0186] Figure 24 Is a general schematic diagram of the medical component 1000, which includes the tool 100 and the external fixed strut 200. The external fixed strut 200 has a rotatable adjustment mechanism 201 for length adjustment as disclosed above.
[0187] The same solution naturally applies to different embodiments 200’, 200”, 200’” of the external fixed strut 200.
[0188] As previously mentioned, the external fixed strut 200 includes a second connection part 205 for data communication with the tool 100. On the other hand, the tool 100 includes a first connection part 105 that is adapted to communicate with the external fixed strut 200 through the second connection part 205 for data communication.
[0189] Thus, as previously described, the first connection portion 105 and the second connection portion 205 also implement data transmission between the external fixing strut 200 and the controller 104 of the tool 100, such as data transmission from the sensors of the external fixing strut 200 to the controller 104.
[0190] In operation, the controller 104 is first configured to allow the tool 100 to be associated with the case of a specific patient. For example, the controller 104 can allow information related to the patient to be loaded into the memory of the tool 100 and the information to be called when needed (e.g., once the tool 100 is turned on at the beginning of the association phase). Then, the surgeon (or any other authorized operator) can confirm the performed association and proceed to the next operation step, for example, by pressing one of the buttons of the tool 100 (e.g., button 1). In this way, the first association is performed and confirmed by the surgeon, thus setting up the tool for use by subsequent patients.
[0191] Suitably, once associated with a specific patient, the controller 104 is configured to download prescription data (herein referred to as "DATA") related to the patient from the above-mentioned external unit (herein identified by reference numeral 300), such as a cloud unit. In some embodiments, the download can be performed automatically.
[0192] The external unit 300 can be, for example, a web server that the tool 100 can access directly or indirectly through its device TX.
[0193] For example, the tool 100 can be connected to a user device 310, such as a smartphone, through the device TX. The user device 310 is equipped with a suitable application or is capable of accessing a dedicated internet portal to perform the connection to the external unit 300 and download the prescription data DATA into the tool 100, particularly into its memory.
[0194] Therefore, the download of data can be performed directly through the tool 100 itself or indirectly through the user device, which also applies to subsequent update data to be downloaded.
[0195] The prescription data DATA is related to the patient case associated with the tool 100 and includes information and instructions for performing the adjustment of the external fixing strut 200 of the patient, such as a set of dates and / or times at which the adjustment of the external fixing strut 200 is to be applied, and the degree of the adjustment, such as in terms of the strut length at each adjustment step.
[0196] It has been observed that each prescription has a validity period. If the prescription is not downloaded within the validity period, the prescription becomes invalid and no other treatment is allowed.
[0197] Once the download is complete, the surgeon (or any other suitable operator) can confirm by pressing one of the buttons of the tool 100, such as button 1. Thus, in the standard setup operation, the surgeon confirms the successful download of the prescription data DATA, as described above. As will be discussed below, in the case of a prescription update, the patient can receive the update (e.g., via a mobile application), and then the patient can confirm the download of the updated prescription and confirm the success of the download.
[0198] Once the surgeon (or any other suitable operator) has completed the above preliminary operations (i.e., preliminary association and prescription download), the controller 104 places the tool 100 in a waiting state, e.g., after further pressing one of the buttons, in which the tool waits for a preliminary coupling with the patient's external fixation strut 200, particularly for data communication with the external fixation strut 200 via the first connection part 105.
[0199] Also in this case, this preliminary coupling is performed by the surgeon (or any other suitable operator); in particular, after the tool 100 has been connected to the external fixation strut 200 during the preliminary coupling operation, the controller 104 is able to automatically recognize the coupling state of the tool 100 with the external fixation strut 200 and signal that coupling state.
[0200] Then, based on this coupling, the controller 104 communicates with the external fixation strut 200 via the first connection part 105 and the second connection part 205, particularly for performing data communication.
[0201] In particular, during this preliminary coupling, the controller 104 is able to write an ID to the strut memory in order to provide a unique identification for a brand-new strut or to recode a mis-coded strut. In other words, during the said preliminary coupling, the controller 104 is configured to assign a strut ID to the external fixation strut 200 for its identification.
[0202] During this coupling, it is also possible to exchange other preliminary information with the strut (e.g., if an ID has been assigned, reading the said ID, and reading the length of the strut, which will be described in detail below).
[0203] Then, after having been coupled with the external fixation strut 200 and having exchanged preliminary information with it (i.e., after the above preliminary coupling), the tool 100 (i.e., its controller 104) enters an idle state (e.g., after further pressing a button after the coupling is completed), in which the tool 100 waits for a specified time / date for strut adjustment to be applied.
[0204] In this idle state, the patient can also check the next adjustment date / time, e.g., by pressing a button of the tool 100.
[0205] When the date and / or time for strut adjustment is reached, the tool 100 can generate an alarm (which can be a visual and / or audible alarm), and the patient can press a button (such as button 1) of the tool 100; then, the controller 104 is configured to put the tool 100 into another waiting state, in which the tool 100 waits for continuous mechanical coupling with the external fixation strut 200 in order to apply a prescribed adjustment thereto. This continuous coupling operation involves mechanical engagement between the tool 100 and the tool 200, and it is typically performed by the patient.
[0206] The controller 104 is configured to wake up the tool 100 due to the upcoming treatment. In one embodiment, the wake-up of the tool 100 is performed by using an internal RTC.
[0207] In one embodiment, when there is an upcoming treatment, the controller 104 is also programmed to estimate the power budget to complete the entire treatment.
[0208] Then, when the patient mechanically engages the tool 100 with the external fixation strut 200, the controller 104 is configured to automatically apply a prescribed adjustment by driving dedicated devices of the tool 100, which act on the rotatable adjustment mechanism 201 of the external fixation strut 200. More specifically, the controller 104 is configured to drive the motor 102 of the tool 100 according to the prescription data DATA in order to apply an appropriate adjustment to the strut 200. As will be discussed below, the length of the external fixation strut 200 can be used to control the driving devices of the tool 100.
[0209] When the tool 100 is engaged with the external fixation strut for correction, when the tool has successfully adjusted the graduated length of the strut, the patient is notified, and by pressing the button again (such as button 1), the tool can return to the idle state again.
[0210] Typically, the fixation device includes a plurality of struts, such as six struts. Therefore, after completing the coupling with one external fixation strut, the controller 104 is configured to check whether the tool 100 is to engage other external fixation struts, and if so, to put the tool 100 into a waiting state (such as after pressing a button), in which the tool 100 waits for coupling with the other external fixation strut. This applies both to the initial coupling performed by the surgeon and to the mechanical engagement performed by the patient, where the patient is precisely guided and errors are avoided due to previous pairing and error message generation.
[0211] Thus, in one embodiment, after the surgeon performs an initial pairing between the tool 100 and the strut 200, the tool 100 knows exactly the identity of each strut 200 of the external fixation device (e.g., which is the correct strut 1, strut 2, etc.). In this way, if the patient engages the wrong strut, the tool 100 is adapted to return this feedback to the user and thus generate a warning in the form of an error message, so that the patient knows that they are engaging the wrong strut.
[0212] When the patient engages the strut 200 with the tool 100, the tool 100 obtains useful information (herein referred to as "INFO") from the external fixation strut 200, such as the length of the strut 200.
[0213] In one embodiment, the actual length of the external fixation strut 200 is obtained by the controller 104 by reading the data of the position sensor 214 of the external fixation strut 200.
[0214] Therefore, the information INFO (exchanged during successive couplings performed by the patient) can be related to a measured value indicating the length of the external fixation strut 200, and when the tool 100 is coupled to the external fixation strut 200, the controller 104 is configured to obtain at least the length from the position sensor 2014 of the external fixation strut 200. Then, when the tool 100 is driven according to the prescription data DATA, this value can be used for feedback control in successive adjustment steps.
[0215] In addition, as part of the information INFO, other information can also be exchanged, such as the strut ID for identifying the external fixation strut 200 or any other useful information.
[0216] As previously mentioned, the tool 100 is configured to generate an alarm when the date and / or time for a prescribed adjustment is reached, so that the patient can couple the tool 100 to the strut 200 in a timely manner when needed. However, the user can also postpone applying the adjustment to the external fixation strut 200, for example by pressing one of the buttons of the tool 100 when the alarm is generated; in one embodiment, by pressing button 1, the tool enters a waiting state, in which the tool waits to be coupled to the strut, while by pressing button 2, the correction is postponed.
[0217] More specifically, in one embodiment, when a correction is to be applied and an alarm is generated, the controller 104 is programmed such that the patient has the following options:
[0218] - Perform the entire correction immediately;
[0219] - Perform a partial correction immediately;
[0220] - Pause the alarm on the tool and postpone the correction, without performing any correction until the next adjustment is applied;
[0221] - Suspend the alarm on the tool and defer the correction, where the correction is applied at any time between the deferral operation and the next adjustment to be applied.
[0222] If the correction is deferred and the user takes no action before the next correction, the deferred correction will be automatically executed during the next correction; in this case, the deferred correction will be added to the standard correction to be applied in the next correction step. In one embodiment, when deferral is selected (or when a partial correction is performed), the amount of correction added in the next correction step is based on the time elapsed since the last applied correction.
[0223] Furthermore, as previously mentioned, according to one embodiment of the present disclosure, the controller 104 is configured to detect an update of the prescription data DATA from the external unit 300 and download the update directly or indirectly through the user device 310 into its memory to replace the previously downloaded prescription data with the updated prescription data, so that the correct prescription can always be applied.
[0224] Therefore, it is clear that the automation of the operation of the tool 100 avoids patient errors, improves the entire postoperative adjustment process, and the patient is properly guided in all steps of the tool 100.
[0225] Figure 25 is a block diagram of an exemplary architecture and connections according to an embodiment of the present disclosure, where only the data connections are shown for clarity.
[0226] In the example shown, the controller 104 of the tool 100 includes a main board 600 that integrates appropriate software modules for implementing the functions of the tool 100 that have been disclosed above.
[0227] The communication module 601 is configured to establish a communication protocol with the strut 200. The communication between the tool 100 and the struts 200, 200', 200", 200'" can be carried out through a DC coupling bus, through which both power and data are transmitted. In one embodiment, the communication is carried out on a half-duplex serial bus, on which data is written to or read from the struts 200, 200', 200", 200'".
[0228] The communication module 601 performs two main functions, namely writing an identification code to provide an identity ID for a brand-new strut or recoding a mis-coded strut (as shown above, this operation is performed by the surgeon or any other suitable operator), and reading the strut ID (which can be performed in both the surgeon and patient modes to read the ID of the strut after the strut is coupled to the tool).
[0229] The communication module 601 is also configured to allow the reading of the length and position of the strut through the strut sensor.
[0230] The controller 104 is also programmed to execute a power management module 602, which is configured to manage all power paths of the tool 100.
[0231] The controller 104 is also programmed to execute a USB data connection module 603 and a motor management / encoder module 604.
[0232] More specifically, the motor management / encoder module 604 is configured to ensure the correct driving of the motor (which can be a brushed motor). The hardware for driving the motor is capable of detecting motor faults / overloads, setting speeds, and verifying whether the target speed is reached using a closed-loop PID. In particular, motor acceleration and deceleration ramps are executed, and the operation is controlled by the closed-loop PID by reading Hall sensors as feedback.
[0233] In addition, the buzzer / LED ring module 605 is executed as part of a safety module, which is configured to notify the operator / patient when an error, warning, or notification occurs, as shown above. The sound signal can have a predetermined pattern, which can vary according to the situation, and the sound signal is associated with the corresponding LED color. The LED ring 120 is driven by a serial cascade bus (shift register), which is capable of sending color and intensity information to the LED. This operation is continuously executed to ensure that the correct color is always prompted according to the alarms activated on the system.
[0234] Then, the software module includes a keyboard management module 606, which is configured to recognize the pressing of the buttons of the tool 100 and trigger appropriate actions.
[0235] Then, the software module includes an external flash and Ram module 607 and a display module 608.
[0236] In addition, the connection module 609 is configured to be able to connect to an external device 300, for example, to check for new firmware updates, check for new prescriptions, upload the last life counter, logs, or any data that must be loaded to the cloud, receive commands to enable certain specific operating modes of the tool 100 (e.g., maintenance mode or surgeon mode), etc.
[0237] Finally, the safety module 610 is configured to ensure the proper and safe operation of the tool.
[0238] As part of the safety module, during treatment, the prescribed elongation can be monitored either by reading the feedback data of the strut sensor or by the rotation of the motor shaft. Considering the gearbox reduction ratio between the motor and the strut of the tool 100, the correct algorithm will be carried out. If the values do not match within a certain threshold, the controller is configured to put the tool 100 into a safe mode. In other words, the controller is configured to monitor the rotation of the output shaft 101 and evaluate the gearbox reduction ratio between the motor 102 of the tool 100 and the strut 200.
[0239] The controller 104 can also be configured to generate an interface I1-I23 on the display 116 of the tool 100, and the interface I1-I23 is configured to display the corresponding operating state of the tool 100.
[0240] Figures 26A to 26W An example of an interface displayed on the display of a tool according to an embodiment of the present disclosure is shown. Below will be combined with Figure 27 and Figure 28 These figures will be discussed.
[0241] Figure 27 and Figure 28 show the upper half and the lower half of a flowchart of the operation of the tool 100 disclosed above in combination with Figure 24
[0242] In summary, 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. This can be equivalent to switching from the Figure 26A interface I1 to the Figure 26B interface I2.
[0243] Similar user actions may be required to return the device to the off state (500).
[0244] After a given time from being turned on, the device will be associated with a specific case (502), as shown in the Figure 26C , Figure 26D and Figure 26E interfaces I3, I4, and I5.
[0245] Then, after the user issues a command, the device connects to the Internet and retrieves the prescription data DATA of the patient case from a dedicated portal, and notifies the patient when the prescription treatment data has been successfully transmitted to the tool memory. This is represented by the Figure 26F , Figure 26G and Figure 26H interfaces I6, I7, and I8.
[0246] As described above, there are various ways (such as GSM, BT, NFC, WiFi) to directly or indirectly connect to the external unit 300, and the present disclosure is not limited by the communication method adopted.
[0247] 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, as Figure 26I shown in interface I9 of
[0248] Once the user issues a command, such as pressing button 1, the device enters a coupling waiting state (505), and the device will signal via the display 116 that it is ready to connect to a given strut, as Figure 26J shown in interface I10 of
[0249] In the coupling waiting state (505), it is expected that the user will mechanically couple the device to the strut 200, which, as described above, will also result in the establishment of a data connection. When the tool is being coupled to the strut, the tool indicates this via Figure 26K the interface I11 of Figure 26L and when the coupling is complete, the tool indicates this via
[0250] the interface I12 of
[0251] Once the data connection is complete (507), the device prompts the user, and then the user can couple other struts 200 in a similar manner. Figure 26M shown in interface I13 of
[0252] Then, once the user issues a command, the device enters an idle state (509) ( Figure 26N the interface I14 of ), ready to signal when the specified correction date and / or time (510) is reached. In this state, the user can query the device, for example by pressing button 1, and then the next correction time (511) will be displayed (interface I15 of Figure 260).
[0253] Then, when the correction time (510) is finally reached, the user can be notified via an audio and / or visual signal that action is required (as Figure 26P shown in interface I16 of
[0254] Then, the user will be able to choose to perform or postpone the adjustment of the 512 struts. Buttons 1 and 2 can be alternately used to distinguish between these two options.
[0255] If the user decides to perform the correction, the device will guide the user to engage the strut 200 to be adjusted (513) ( Figure 26Qinterface I17). Once the external fixing rod 200 is engaged, the device will automatically perform adjustment in the adjustment step (514), and then send a signal indicating the completion of adjustment to the user (515)( Figure 26R and Figure 26S interfaces I18 and I19).
[0256] If another rod needs to be adjusted, repeat steps 513 - 515; otherwise, the device sends a signal indicating the completion of correction to the user (516)( Figure 26T interface I20), and returns to the idle state (509).
[0257] Starting from the idle state (509), as long as a prescription update is detected, the device can update the prescription (517)(see Figure 26U 、 Figure 26V and Figure 26W interfaces I21, I22 and I23). When the tool is in the idle state, this update can be activated by the patient pressing a button, or automatically completed by the tool 100 through regular update checks (e.g., by interacting with the external unit 300).
[0258] In one embodiment, the patient or surgeon can engage the tool 100 into a specific rod 200 at any time (except during the correction phase) to obtain its length (state 518), and with the pressing of one or more buttons, the controller 104 is configured to initiate a test of the rod 200 to verify whether both the mechanics and firmware of the rod work as expected (state 520).
[0259] Furthermore, in one embodiment, during the rod adjustment operation, if the patient feels pain during treatment, as a safety mechanism, the tool 100 can be disengaged from the rod 200 (state 522).
[0260] It should be understood that the specific embodiments described herein are for illustrative purposes only and not a limitation of the present disclosure. The main features of the present disclosure can be used in various embodiments without departing from the scope of the present disclosure. Those skilled in the art will recognize, or can determine with only routine experimentation, numerous equivalents to the specific devices and procedures described herein. These equivalents are considered to be within the scope of the present disclosure and are protected by the claims.
[0261] All publications and patent applications mentioned in this specification indicate the professional level of those skilled in the technical field to which the present disclosure pertains. All publications and patent applications are hereby incorporated by reference herein to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
[0262] The "a" or "an" used in connection with the term "comprising" in the claims and / or the specification may mean "one", but also conforms to the meaning of "one or more", "at least one", and "one or more than one". The term "or" used in the claims means "and / or", unless expressly stated to refer only to alternative options or the alternative options are mutually exclusive, although the present disclosure supports the definitions of only alternative options and "and / or".
[0263] The terms "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include"), or "containing" (and any form of containing, such as "contains" and "contain") used in this specification and the claims are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.
[0264] Obviously, those skilled in the art can make various modifications and variations to the above tools to meet the needs of the moment and specific requirements, and all of these fall within the scope of the invention defined by the appended claims.
Claims
1. A programmable wrench (100) for automatically adjusting the length of an external fixed strut (200, 200’, 200”, 200’”), the programmable wrench (100) comprising: A mechanical connector (103) for releasably engaging with the external fixed strut (200, 200’, 200”, 200’), so as to be capable of transferring at least an adjustment torque from the programmable wrench (100) to the external fixed strut (200, 200’, 200”, 200’); An electrical connector (105) for releasably connecting with the external fixed strut (200, 200’, 200”, 200’), so as to be capable of realizing at least data transmission from the external fixed strut (200, 200’, 200”, 200’) to the programmable wrench (100); Wherein, the mechanical connector (103) and the electrical connector (105) are integrated in a common port and jointly engage and disengage with the external fixed strut (200, 200’, 200”, 200’).
2. The programmable wrench (100) according to claim 1, wherein, The electrical connector (105) is further capable of realizing power transmission from the programmable wrench (100) to the external fixed strut (200, 200’, 200”, 200’).
3. The programmable wrench (100) according to claim 1, wherein, The electrical connector (105) defines a wired contact with the external fixed strut (200, 200’, 200”, 200’), a first pole is connected through an internal connector (1050), and a second pole is connected through an external connector (1051).
4. The programmable wrench (100) according to claim 3, wherein, The internal connector (1050) is a spring pin, and the external connector (1051) is a metal spring.
5. An external fixed strut (200, 200’, 200”, 200”), comprising: An elongate body (211), the length of the elongate body (211) being changeable by a rotatable adjustment mechanism (201); A mechanical connector (203) of the adjustment mechanism (201) for releasably engaging with a programmable wrench (100), so as to be capable of transferring at least an adjustment torque from the programmable wrench (100) to the external fixed strut (200, 200’, 200”, 200’); An electrical connector (205) for releasably connecting with the programmable wrench (100), so as to be capable of realizing data and / or power transmission between the external fixed strut (200, 200’, 200”, 200’) and the programmable wrench (100); Wherein, the mechanical connector (203) and the electrical connector (205) are integrated in a common port and jointly engage and disengage with the programmable wrench (100).
6. An external fixed strut (200, 200’, 200”, 200”), comprising: An elongate body (211) having a variable length; At least one sensor (214, 214', 214"), the sensor (214, 214', 214") being embedded in the elongated body (211) and capable of detecting at least a change in the length of the elongated body (211).
7. The external fixing strut (200, 200', 200", 200'") according to claim 6, wherein the external fixing strut (200, 200', 200", 200'") further comprises at least one wired data port which can engage with a programmable wrench (100) for automatically adjusting the length of the external fixing strut (200, 200', 200", 200'") so as to transmit data about the change in the length of the elongated body (211) to the programmable wrench (100).
8. The external fixing strut (200, 200’, 200”, 200’”) according to claim 7, wherein, The sensor (214, 214', 214") is a position sensor which detects the position of a first axis (212) of the elongated body (211) relative to a second axis (213), the first axis (212) and the second axis (213) being telescopically connected to define the elongated body (211).
9. The external fixing strut (200, 200’, 200”, 200’’’) according to claim 8, wherein, The sensor (214, 214', 214") is an inductive sensor or a capacitive sensor.
10. The external fixing strut (200, 200’, 200”, 200’’’) according to claim 9, wherein, The sensor (214, 214', 214") detects the position of a measuring cursor (219, 219') along a sensing strip (2142), the measuring cursor (219, 219') being integral with one of the first axis (212) or the second axis (213), and the sensing strip (2142) being integral with the other of the first axis (212) or the second axis (213).
11. A programmable wrench (100) for automatically adjusting the length of an external fixation strut (200, 200’, 200”, 200’’’) of an external fixation system, wherein, The programmable wrench (100) is adapted to: - obtain prescription data (data) which is related to a determined patient case and includes instructions for performing the adjustment of the external fixing strut (200) of the patient; - guide the user to perform the adjustment of the external fixing strut (200, 200', 200", 200'") according to the prescription data (data); - update the state of the external fixing system according to the readings of length sensors (214, 214', 214") embedded in each external fixing strut (200, 200', 200", 200').
12. The programmable wrench (100) according to claim 11, wherein, The step of guiding the user to perform the adjustment of the external fixing strut (200, 200', 200", 200'") at least includes a sub-step of indicating to the user which external fixing strut (200, 200', 200", 200") needs to be adjusted.
13. The programmable wrench (100) according to claim 12, wherein, In the step of guiding the user to perform the adjustment of the external fixing strut (200, 200', 200", 200'), the starting direction and starting time of the wrench are automatically calculated according to the currently engaged strut (200, 200', 200", 200") and the updated prescription data (Data).
14. The programmable wrench (100) according to claim 13, wherein, The starting time is feedback-controlled according to the readings of the length sensors of the externally fixed support rods (200, 200’, 200”, 200’’’) that have been engaged.
15. The programmable wrench (100) according to claim 11, wherein, The programmable wrench (100) includes ports for connecting to the externally fixed support rods (200, 200’, 200”, 200’’’), and the programmable wrench (100) can clearly identify the externally fixed support rods connected thereto through the ports.
Citation Information
Patent Citations
Tool and method for external fixation strut adjustment
WO2009105479A1