One-way tightening assembly for a tensioning device for a circular large cable, and a tensioning device for a circular large cable comprising such a one-way tightening assembly

Abstract

The present invention relates to a one-way clamping assembly (1, 3) for a tensioning device (10) for a circular cable (C) for treating fractured bones. The clamping assembly (1, 3) can have a locking configuration in which the circular cable (C) can slide in one direction, and a release configuration in which the circular cable (C) can slide in both directions. The clamping assembly (1, 3) comprises a wedge element (11) that, when rotated, moves the clamping assembly (1, 3) from the locking configuration to the release configuration and vice versa, and a push means (19) that can lock the rotation of the wedge element (11) in both the locking and release configurations, thereby allowing the clamping assembly (1, 3) to maintain these configurations.

Description

TECHNICAL FIELD

[0001] The present invention relates to a one-way tightening assembly for a cerclage cable tensioning device. The present invention further relates to a cerclage cable tensioning device comprising such a one-way tightening assembly.

[0002] By way of non-limiting example, such a tensioning device can be used to treat fractured bones. The present invention also relates to a method for applying tension to such a cerclage cable by means of the aforementioned tensioning device. BACKGROUND ART

[0003] In the field of orthopedic surgery, it is known to use cerclage wires in cases of very severe fractures or bone reconstruction surgeries. Such cerclage wires are permanently implanted to keep bone fragments in a bonded state and / or to keep a bone plate firmly bonded to the bone.

[0004] Within the scope of the present patent application, the term "cable" includes single-wire cables, single-strand cables, multi-wire cables, and multi-strand cables. The above cables are generally metal cables, but it is also known to use plastic cables.

[0005] In particular, the purpose of the aforementioned cerclage cable is to apply a circumferential compressive force to the bone fragments, and to achieve such a purpose, the cerclage cable is tightened around the bone and then locked.

[0006] Typically, these cerclage cables are implanted by a suitable tensioning device, which is intended to apply a specific tension to the cable to tighten it firmly around the bone and / or plate.

[0007] Once the clamping tension is reached, the excess cable portion is crimped so that a permanent clamping ring remains around the bone and / or plate. A very common tension-applying device is shown in Figure 1.

[0008] The tensioning device shown in reference no. 100 comprises an elongated body 110, an operating rod 120 that can slide within the elongated body 110, a first tightening assembly 130a and a second tightening assembly 130b that are firmly connected to the operating rod 120.

[0009] The clamping assembly through which the circular cable passes can be switched between a release configuration that allows the cable to slide freely within the assembly and a locking configuration that prevents the cable from sliding.

[0010] First, the first tightening assembly 130a is set to a locked configuration and the second tightening assembly 130b is set to a released configuration. Then, the operating rod 20 is slid so as to move the tightening assembly 130b away from the tightening assembly 130b, thereby applying tension to the circular cable.

[0011] However, a single translational movement of the actuarial rod 120 is often insufficient to obtain the desired tension. In order to repeat the process of applying tension, it is necessary to return the operating rod 120 to its initial position by sliding it in the opposite direction to the direction in which tension is applied.

[0012] To enable such operations, the second tightening assembly 130b must be configured to lock so that the tension applied to the cable is maintained, and the first tightening assembly 130a must be configured to release so that the actuation rod 120 can slide.

[0013] Subsequently, tension can be maintained on the cable by returning the first tightening assembly 130a to the locked configuration and the second tightening assembly 130b to the released configuration. Therefore, such steps must be repeated until the desired tension is reached.

[0014] The type of tension-applying device shown in Figure 1 is known, for example, from the document published in U.S. Patent Application No. 2013 / 085504. As can be easily inferred, this tensioning device involves frequent changes to the configuration of the locking unit and intermittent tensioning, making it extremely complex to use and difficult to operate, increasing the stress on healthcare workers and prolonging the time required to tighten the cable around the bone and / or plate.

[0015] The long and complex operation of this tension-applying device significantly increases the surgical time, forcing patients to remain under general anesthesia for longer periods, thus increasing the risk of complications and prolonging the postoperative recovery time.

[0016] The intermittent tensioning of the circular cable also generates shock waves, which can damage already injured bone and lead to inaccurate cable tightening and positioning during implantation.

[0017] Finally, frequent locking and unlocking of large-circuit cables increases the likelihood of fraying, resulting in sharp edges that could injure healthcare workers when handling the cables.

[0018] To overcome these constraints, unidirectional clamping assemblies were developed. Specifically, clamping assemblies were developed that lock the cable in a locking configuration, preventing it from sliding in one direction, while allowing it to slide in the opposite direction, i.e., the direction in which tension is applied to the cable.

[0019] Referring to Figure 2, a known type of one-way clamping assembly 200 is shown, which is constructed as follows: The assembly comprises a housing channel 210 into which a circular large cable is inserted, and a wedge element 220. A spring 230 acts on the wedge element, which is configured as a cam, and the spring biases the wedge element 220 toward the wall 210a of the housing channel 210 such that the wedge element 220 applies locking pressure to the circular large cable positioned between the wedge cable 220 and the wall 210a.

[0020] If the clamping assembly 200 is in a locking configuration and a force is applied to the circular large cable in a direction that puts tension on the circular large cable, such force pushes the wedge element 220 such that the contour of the wedge element 220 rotates away from the wall 210a, thereby allowing the circular large cable to slide in the same direction as the force.

[0021] When a force is applied to the cable in the opposite direction, the force causes the circular large cable to loosen, but such a force pushes the wedge element 220 so that it rotates in the direction that it is wedge-fixed to the wall 210a, thereby preventing the circular large cable positioned between the elements from sliding in that direction.

[0022] To disengage the clamping assembly, the wedge element can be moved away from the wall 210a by manually manipulating a portion 220a of the wedge element 220 so as to overcome the pushing force of the spring 230.

[0023] A tensioning device with such a unidirectional clamping assembly is known from the literature EP625336. While such one-way clamping assemblies have proven effective in reducing the steps required to tension large circular cables and preventing intermittent tensioning, they are not without their drawbacks and certainly have room for improvement.

[0024] In particular, in EP625336, as soon as the portion 220a of the wedge element 220 is released, the interaction between the spring 230 and the wedge element 220 presses the wedge element back against the wall 210a, thereby returning to the locked configuration, so it is necessary to keep acting on the portion 220a in order to be able to maintain the one-way clamping device in the released configuration.

[0025] Accordingly, currently known one-way clamping assemblies have one major limitation, namely that they cannot be locked in the released configuration. As a result, when the clamping assembly is held in the released configuration, inserting and withdrawing the cerclage cable into and from the assembly can be a very complex operation for a single surgeon to perform, since the surgeon must continue to manipulate the portion 220a with one hand for the entire duration of such operation.

[0026] Continuing to manipulate this portion for an extended period of time can also cause fatigue and numbness in the surgeon's hand, which inevitably degrades the quality of the surgery. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0027] The main object of the present invention is to provide a one-way clamping assembly and a tensioning device comprising the one-way clamping assembly that make it possible to eliminate, or at least minimize, the above-mentioned drawbacks. MEANS FOR SOLVING THE PROBLEMS

[0028] These and other objects are achieved with the one-way clamping assembly for a cerclage cable tensioning device and the cerclage cable tensioning device as claimed in the appended claims.

[0029] One-way tightening assemblies are applied in known embodiments to tensioning devices used to increase the tension on a circular cable and tighten the circular cable around the bones of a patient.

[0030] In a known embodiment, the one-way clamping assembly comprises a body having a wedge chamber and a housing channel that penetrates the body from one end to the other and communicates with the wedge chamber.

[0031] As is known, a one-way clamping assembly further comprises a wedge element rotatably connected to the above body by a connecting pin. The wedge element comprises a lever system extending outward from the main body and suitable for operation by a user to control the rotation of the wedge element, and a main body substantially located inside the wedge chamber and having defined engaging portion facing the wedge chamber and control portion facing in the opposite direction from the engaging portion.

[0032] The engaging portion is shaped such that the wedge element cannot rotate completely around the connecting pin, but instead wedges into the wall of the wedge chamber (hereinafter referred to as the "fastening wall"). As is known, the one-way clamping assembly further comprises a pressing means suitable for interacting with the wedge element.

[0033] According to the present invention, the contour of the control unit comprises an edge portion, preferably a rounded edge portion, that separates the contour into a first control contour portion located away from the housing channel and a second control contour portion located near the housing channel.

[0034] Furthermore, according to the present invention, the pressing means acts indirectly on the control unit. In particular, the connecting element is provided between the control unit and the pushing means. According to a preferred embodiment of the present invention, the pressing means is a spring, preferably a compression spring (also known as a "coil spring").

[0035] According to a preferred embodiment of the present invention, the connecting element is a sphere. During operation, the circular large cable is slid along the housing channel so that a portion of the circular large cable passes through the wedge chamber.

[0036] Thus, the circular large cable portion positioned in the wedge chamber is placed between the engaging portion and the clamping wall of the wedge chamber. Once the circular cable passes through the main body, the clamping assembly can take on two different configurations by operating the lever system of the wedge element.

[0037] In the first configuration (referred to as the "locking configuration"), the connecting element is in contact with the first control contour. This interaction between the connecting element and the first control contour causes the engaging portion to press the circular cable portion against the clamping wall of the wedge chamber.

[0038] According to the present invention, even when the lever system is released, the one-way clamping assembly can maintain its locking configuration due to the interaction between the first control contour and the connecting element. In this configuration, the clamping assembly can operate in two ways depending on the direction of the tension applied to the circular cable.

[0039] When the circular large cable is subjected to tension in a direction consistent with the compression direction of the pressing means, the frictional force between the engaging portion and the circular large cable causes the wedge element to rotate in a direction that reduces the locking pressure exerted on the circular large cable portion by the engaging portion, thereby allowing the cable to move in the same direction as the tension.

[0040] Instead, when the circular large cable is subjected to tension in a direction consistent with the direction in which the pushing means extends, the frictional force between the engaging portion and the circular large cable causes the wedge element to rotate in a direction that increases the locking pressure exerted by the engaging portion on the circular large cable portion, thereby preventing the cable from sliding in the same direction as the tension.

[0041] This duality of the clamping assembly's operation allows for unidirectional locking of the cable slide, i.e., automatic locking of the cable in a certain direction. It should be noted that by manually operating the lever system, the engaging portion can be further pressed against the circular cable, thereby locking the cable in both directions.

[0042] The above tightening assembly can also take on a second configuration called the “release configuration”. In the second configuration, the connecting element interacts with the second control contour, and as a result, the engaging portion moves away from the clamping wall of the wedge chamber.

[0043] Therefore, the locking pressure exerted on the circular cable portion by the engaging portion is significantly reduced (or eliminated), thereby allowing the cable to slide in both directions relative to the clamping assembly.

[0044] This configuration is initially used to easily insert the circular cable into the main body without the engaging part interfering with this operation, and then, once tensioning of the cable is complete, it is used to pull the cable out of the main body.

[0045] In particular, according to the present invention, thanks to the special contour of the control unit and the interaction between the contour and the connecting element, the connecting element pressed against the control unit by the pushing means locks the rotation of the wedge element, thereby keeping the engaging portion away from the clamping wall even when the lever system is released.

[0046] Therefore, by providing the above-mentioned connecting element along with the special contour of the control unit, the tightening assembly of the present invention can remain locked in the release configuration. According to a preferred embodiment of the present invention, the lever system of the wedge element comprises a closing lever for locking the fastening assembly and an opening lever for releasing the fastening assembly.

[0047] According to a preferred embodiment of the present invention, the engaging portion that interacts with the circular large cable when the clamping assembly is in a locking configuration may be provided with appropriate knurling to increase the clamping force applied to the circular large cable.

[0048] According to another aspect of the present invention, a tension-applying device comprising the above-described unidirectional tightening device is provided. By providing the above-described unidirectional tightening assembly, it is advantageous to obtain a tensioning device that is easier to operate. This is because, when the tightening assembly is locked in the release configuration, the user can use both hands to operate the circular large cable or perform other operations during surgery, thus improving the quality of the surgery and reducing the risk of inaccuracy and error.

[0049] The tensioning device using the unidirectional tightening assembly of the present invention offers improved operability, thereby reducing the time required to achieve tightening of the circular cable around the patient's bone.

[0050] Another aspect of the present invention provides a method for applying tension to a circular large cable for tightening the circular large cable with a tensioning device comprising the above-described one-way tightening assembly.

[0051] The above method of applying tension is a) The step of attaching the end of the circular cable to the surgical connector at the surgical site, b) The step of preparing a tensioning device equipped with a unidirectional tightening assembly according to the present invention, c) The step of disengaging the one-way clamping assembly by operating the lever system of the one-way clamping assembly, d) A step of passing the opposite end of the above-mentioned circular large cable through the above-mentioned one-way tightening assembly, wherein it is advantageous that this operation can be performed with both hands since the one-way tightening assembly maintains a release configuration, e) The step of locking the one-way clamping assembly by operating the lever system of the one-way clamping assembly, f) A step of controlling the sliding of the circular large cable in a direction permitted by the locking configuration relative to the one-way clamping assembly, by operating the tensioning device, such sliding can increase the tension on the circular large cable, given that the end of the circular large cable is attached to a surgical connector. Includes. Further features and advantages of the present invention will become apparent from the following detailed description of preferred embodiments shown as non-limiting examples, with reference to the accompanying figures. [Brief explanation of the drawing]

[0052] [Figure 1] This is a diagram of a known type of tensioning device for tightening a large circular cable. [Figure 2] This is a diagram of a known type of one-way clamping assembly for a large circular cable. [Figure 3] This is a diagram of a tensioning device having two unidirectional clamping assemblies according to the present invention. [Figure 4] Figure 3 is a cross-sectional view of the tension-applying device. [Figure 5] This is a diagram of a one-way clamping assembly according to the present invention, shown in a locking configuration. [Figure 6] This is a diagram of a one-way clamping assembly according to the present invention, shown in a release configuration. [Modes for carrying out the invention]

[0053] The following description of preferred embodiments of a unidirectional tightening assembly for a tensioning device for a circular large cable refers to a tensioning device configured as a gun-type tensioner and used for the treatment of femoral fractures.

[0054] However, such applications should not be interpreted in a limited sense, and the one-way clamping assembly according to the present invention can also be used in other types of tensioning devices, or in tensioning devices used for fixing other types of fractures, spinal reconstruction surgery, total hip replacement, sternal closure, and other surgical procedures.

[0055] Referring to Figures 3 and 4, in the illustrated embodiment, the tensioning device 10, shown mounted and ready for use, comprises two clamping assemblies 1 and 3. According to the illustrated embodiment, both clamping assemblies 1 and 3 are one-way clamping assemblies.

[0056] However, in alternative embodiments, the tensioning device 10 may have a single unidirectional clamping device, or it may have a unidirectional clamping device associated with a clamping assembly of a known type, which is not even a unidirectional clamping assembly.

[0057] When describing the tension-applying device of the present invention, the term "proximal" refers to a direction / part of the tension-applying device 10 that is close to the user and farther from the patient, while the term "distal" refers to a direction / part of the tension-applying device 10 that is farther from the user and closer to the patient.

[0058] The "proximal end" of the tension-applying device 10 is shown on the right side of Figures 3 and 4, and the "proximal direction" indicated by arrow "A" represents any movement toward the user. The "distal end" of the tension-applying device 10 is shown on the left side of Figures 3 and 4, and the "distal direction" indicated by arrow "B" represents any movement toward the patient.

[0059] As can be seen in Figure 3, the tension-applying device 10 comprises an elongated body 10a having a proximal end and a distal end as defined above, and a longitudinal axis extending between the proximal end and the distal end.

[0060] A one-way clamping assembly 1 (hereinafter referred to as the distal clamping assembly) is attached to the distal end of the elongated main body 10a described above. A one-way clamping assembly 3 (hereinafter referred to as the proximal clamping assembly) is attached to the proximal end of the elongated main body 10a described above.

[0061] The distal clamping assembly 1 and the proximal clamping assembly 3 are aligned in a straight line with each other, spaced apart in the longitudinal direction from each other, and spaced apart from the elongated main body 10a, so that the circular large cable C can pass through them.

[0062] Both distal clamping assembly 1 and proximal clamping assembly 3 are, - The above clamping assembly has a locking configuration that allows the circular large cable C to slide proximal (arrow "A") and prevents the circular large cable C from sliding distal (arrow "B"). - Release configuration that allows sliding of the circular large cable C in both directions It is possible to take it. These directions are parallel to the longitudinal axis of the elongated body 10a in both the locking and unlocking configurations.

[0063] As shown in Figure 4, the tensioning device 10 is housed in an elongated body 10a and further comprises an operating rod 20 connected to the proximal tightening assembly 3 and a lever actuator 30 rotatably connected to the elongated body 10a, wherein the rotation of the lever actuator controls the longitudinal movement of the operating lever 20 in the proximal direction.

[0064] Therefore, the longitudinal movement of the operating lever 20 causes the corresponding longitudinal movement of the proximal clamping assembly 3. Therefore, considering the proximal clamping assembly 3 in the locking configuration, such longitudinal movement can increase the tension on the circular cable C.

[0065] The tension-applying device 10 further includes a handle 40 connected to an elongated body 10a. This handle is configured to allow the user to easily control the sliding of the operating rod 20 by moving the lever actuator 30 toward the handle 40, without needing to directly grasp the elongated body 10a.

[0066] The tension-applying device 10 further includes a stopper 50 configured to allow the operating rod 20 to move in the proximal direction and, at the same time, to prevent the rod from sliding in the distal direction, thereby maintaining tension on the circular large cable C when the lever actuator 30 is operated.

[0067] Finally, the tension-applying device 10 includes a release lever 60 rotatably connected to an elongated body 10a. When the release lever 60 is activated, the stopper 50 can be released, and as a result, once the movement of the operating rod 20 is complete, the operating rod and the proximal tightening assembly 3 connected thereto can slide distally back to their initial positions.

[0068] Figures 5 and 6 show the distal clamping assembly 1. As can be seen in the figure above, the distal clamping assembly 1 comprises a main body 5 in which a wedge chamber 7 and a housing channel 9 are defined.

[0069] The housing channel 9 extends through the body 5 from one end to the other, along a direction parallel to the longitudinal axis of the elongated body 10a, and is in communication with the wedge chamber 7. The distal clamping assembly 1 further comprises a wedge element 11 that is rotatably connected to the main body 5 by a connecting pin 15.

[0070] The wedge element 11 comprises a main body 13 substantially located inside the wedge chamber 7 and an engaging portion 17 facing the wedge chamber 7. The wedge element 11 is not capable of completely rotating around the connecting pin 15, but rather is shaped to wedge against the wall 7a of the wedge chamber 7 (hereinafter referred to as the "fastening wall").

[0071] The main body 13 of the wedge element 11 further includes a control unit 18 facing in the opposite direction to the engaging portion 17. In particular, the contour of the control unit 18 comprises a first control contour portion 18a', a second control contour portion 18a'', and preferably a rounded edge portion 18a'''' located between the first and second control contour portions.

[0072] The distal clamping assembly 1 further comprises a spring 19, preferably a compression spring (also known as a "coil spring"). In particular, since a sphere 21 that functions as a connecting element between these elements is provided between the control unit 18 and the spring 19, the spring 19 acts indirectly on the control unit 18 of the wedge element 11.

[0073] Alternatively, the sphere 21 may be replaced with any connecting element that can be connected to the control unit 18 and spring 19 of the wedge element 11. Alternatively, the spring 19 may be replaced with any pushing means that can interact with the control unit 18 through the sphere 21.

[0074] The wedge element 11 further comprises a lever system that extends outside the main body 5 so that it can be operated by the user. According to the embodiments shown in Figures 5 and 6, the lever system is - A closing lever 23, which is positioned on the same side as the spring 19 with respect to the vertical axis passing through the connecting pin 15, such that when the lever is operated, the wedge element 11 rotates and the distal clamping assembly 1 is locked. - An open lever 25, which is positioned on the opposite side of the side where the pushing means 19 is located with respect to the vertical axis passing through the connecting pin 15, such that when the lever is operated, the wedge element 11 rotates and the distal tightening assembly 1 is released. It is equipped with.

[0075] Alternatively, the above lever system may include a single lever capable of performing both closing and opening functions. During operation, the large circular cable C passes through the main unit 5.

[0076] In particular, the above-mentioned large circular cable C starts from the inlet opening 27 of the main body 5 which communicates with the housing channel 9, slides along the housing channel 9, passes through the wedge chamber 7, and exits through the outlet opening 29 of the main body 5 which is located at the end opposite to the inlet opening 27.

[0077] As can be seen in Figure 5, a portion of the circular large cable C in the wedge chamber 7 is positioned between the main body 13 of the wedge element 11 and the clamping wall 7a of the wedge chamber 7. In particular, Figure 5 shows the distal clamping assembly 1 of the locking configuration.

[0078] In this configuration, the edge portion 18a'' of the control unit 18 is closer to the plane defined by the clamping wall 7a than to the tangential contact point between the sphere 21 and the control unit 18. As a result, the spring 19 interacts with the sphere 21 and acts on the first control contour portion 18a' of the control unit 18.

[0079] Through this interaction, the spring 19 acts to rotate the wedge element 11, and as a result, the engaging portion 17 comes into contact with a part of the circular large cable C, and the circular large cable C also comes into contact with the clamping wall 7a of the wedge chamber 7.

[0080] According to the present invention, even when the closing lever 23 is released, the distal clamping assembly 1 can maintain its locking configuration due to the interaction between the first control contour portion 18a' and the sphere 21. In this configuration, the distal clamping assembly 1 can operate in two ways depending on the direction of the tension applied to the circular cable C.

[0081] When the circular large cable C is subjected to tension in the direction indicated by arrow "A", which coincides with the direction in which the spring 19 is compressed, the wedge element 11 rotates around the connecting pin 15 in a direction opposite to the action of the spring 19 due to the frictional force generated by the contact between the engaging portion 17 and a portion of the circular large cable C, as the control unit 18 interacts with the sphere 21.

[0082] Due to the shape of the arm between the connecting pin 15 and the body 13 of the wedge element 11, and the shape of the body 13 itself, the rotation of the wedge element 11 moves the engaging portion 17 away from the tangential contact point with the clamping wall 7a.

[0083] Therefore, the locking pressure exerted on the cable portion by the engaging portion 17 is reduced, thereby allowing the circular large cable C to move in the same direction as the tension. Instead, when the circular large cable C is subjected to tension in the direction indicated by arrow "B," which coincides with the direction in which the spring 19 stretches, the frictional force generated by the contact between the engaging portion 17 and a portion of the circular large cable C causes the wedge element 11 to rotate around the connecting pin 15 in a direction that assists the pushing action of the spring 19 by the control unit 18 interacting with the sphere 21.

[0084] Therefore, the straight-line distance between the connection point 15 and the tangential contact point between the circular large cable C and the engaging portion 17 becomes longer, and consequently, a portion of the circular large cable C is wedge-fastened to the clamping wall 7a.

[0085] As a result, the locking pressure exerted on a portion of the circular cable C by the engaging portion 17 increases, thereby preventing the cable from sliding in the same direction as the tension. According to the illustrated embodiment, the engaging portion 17 is provided with appropriate knurling, which engages with the twists normally present in the circular large cable C, thereby increasing the tightening that the distal tightening assembly 1 can exert on the circular large cable C.

[0086] This duality of operation of the clamping assembly in the locking configuration allows for unidirectional locking of the cable slide, i.e., automatic locking of the cable in a direction coinciding with the distal direction described above.

[0087] As a result, when the distal clamping assembly 1 is attached to the tensioning device 10, the clamping assembly 1 provides little to no resistance, allowing the cable C to slide in the first direction, thereby enabling tensioning of the large circular cable C.

[0088] At the same time, when it is necessary to return the operating rod 20 to its initial position (this operation interrupts the application of tension to the cable and therefore creates tension in the opposite direction to the direction in which tension is applied), the distal tightening assembly 1 locks the cable in place, allowing the tension achieved up to that point to be maintained.

[0089] Furthermore, starting from the above locking configuration, by pushing the closing lever 23 toward the circular large cable C, the engaging portion 17 can be further pressed against a part of the circular large cable C, thereby locking the cable from sliding in either direction, regardless of the direction of the tension applied to the cable.

[0090] Referring to Figure 6, this shows the distal clamping assembly 1 in the release configuration. This configuration is achieved by manually operating the release lever 25 of the wedge element 11 so that the body 13 of the wedge lever 11 rotates toward the spring 19.

[0091] Thanks to the special contour of the control unit 18, such rotation causes the engaging portion to be lifted relative to the clamping wall 7a of the wedge chamber 7. Therefore, the locking pressure exerted on a portion of the circular cable C by the engaging portion 17 is significantly reduced (or eliminated), thereby allowing the cable to slide in both directions relative to the clamping assembly.

[0092] This configuration is used first to easily insert the circular large cable C into the main body 5 without the engaging portion 17 of the wedge element 11 interfering with this operation, and then to pull the circular large cable C out of the main body 5 once tensioning of the cable is complete.

[0093] In particular, according to the present invention, this rotation of the wedge element 11 causes the edge portion 18a'' of the control unit 18 to move further away from the plane defined by the clamping wall 7a than the tangential contact point between the control unit 18 and the sphere 21, and as a result, the spring 19 acts on the second control contour portion 18a'' by interacting with the sphere 21.

[0094] Thanks to this interaction, even when the lever 25 is released, the engaging portion can be kept in an elevated position relative to the clamping wall 7a. Therefore, by providing the sphere 21, it can be combined with the special contour of the control unit 18 to keep the distal clamping assembly 1 locked in the released configuration.

[0095] Therefore, by using the distal tightening assembly 1 according to the present invention, it is advantageous to obtain a tensioning device 10 that is easier to operate. This is because, when the distal tightening assembly is locked in the release configuration, the user can use both hands to operate the circular large cable C or perform other operations during surgery, thus improving the quality of the surgery and reducing the risk of inaccuracy and error.

[0096] The tension-applying device 10 offers improved operability, thereby reducing the time required to achieve the desired tightening and, consequently, shortening the surgical time. Accordingly, according to another aspect of the present invention, a method is provided for applying tension to a circular large cable C for tightening the circular large cable C with a tensioning device 10 comprising the distal tightening assembly 1 and the proximal tightening assembly 3.

[0097] According to this embodiment, the proximal clamping assembly 3 has the same features and operating principle as the distal clamping assembly 1. The main difference that distinguishes these clamping assemblies is that the body 5 of the distal clamping assembly 1 has connecting parts 31 and 33 located near the inlet opening 27 and the outlet opening 29, respectively, and these connecting parts have a shape and size appropriate to be detachably connected to the respective connecting parts of the tensioning device 10.

[0098] The proximal clamping assembly 3 instead has a single connector that is positioned to be firmly connected to the operating rod 20 of the tensioning device 10. The present invention provides a method for applying tension, a) The step of attaching the end of the circular cable C to the surgical connector at the surgical site, b) A step of preparing a tensioning device 10 configured to move the opposite end of the circular large cable C away from the above end of the circular large cable C, wherein the tensioning device 10 comprises a one-way tightening assembly 1 and a proximal tightening assembly 3, c) The step of disengaging the tightening assembly by operating the lever systems of the distal tightening assembly 1 and the proximal tightening assembly 3, d) A step of passing the opposite end of the circular cable C through the distal tightening assembly 1 and the proximal tightening assembly 3, wherein it is advantageous that this operation can be performed with both hands since both the distal tightening assembly 1 and the proximal tightening assembly 3 maintain their release configurations, and e) The step of locking the clamping assemblies by operating the lever systems of the distal clamping assembly 1 and the proximal clamping assembly 3, f) A step of controlling the slide of the operating rod 20 of the tensioning device 10 by operating the lever actuator 30 of the tensioning device 10 so as to move the opposite end of the circular large cable C away from the end of the circular large cable C, wherein such slide of the proximal clamping assembly 3 can increase the tension on the circular large cable C due to the fact that the end of the circular large cable is attached to a surgical connector. Includes.

[0099] Step f) can be repeated until the operating rod 20 reaches its movable end stop. Moving the operating rod 20 only once is often insufficient to obtain the desired tension, so it is necessary to return the operating lever to its initial position.

[0100] For this purpose, the present method provides a method for controlling the sliding of the operating rod 20 in the opposite direction to the sliding direction of step f) by operating the release lever 60 of the tensioning device 10, thereby returning the operating lever 20 to its initial position.

[0101] Advantageously, the clamping assembly is a unidirectional clamping assembly, and since it can return the operating rod 20 to its initial position while maintaining the tension applied to the circular cable C, this operation can be performed without further modification of the configurations of the distal clamping assembly 1 and the proximal clamping assembly 3.

[0102] Therefore, by providing the one-way tightening assemblies 1 and 3 described above, the operating rod 20 can be slid until it reaches the movable end stopper, and the rod can be quickly and easily returned to its initial position, thereby enabling the optimal tension to be applied to the circular large cable C in a short time.

[0103] From the above, it is clear that the above method of applying tension to the circular large cable C is faster and easier than tensioning methods that involve the use of known types of tensioning devices.

Claims

1. A one-way tightening assembly (1, 3) for a tensioning device (10) for a circular large cable (C), - A locking configuration in which the sliding of the circular cable (C) within the one-way clamping assembly (1, 3) is permitted in a first direction (A) and prevented in a second direction (B), - The sliding of the circular cable (C) within the one-way clamping assembly (1, 3) is permitted in both the first direction (A) and the second direction (B) and the release configuration is such that It is suitable for choosing one of the two options. The aforementioned one-way clamping assembly (1, 3) - A body (5) having a wedge chamber (7) and a housing channel (9) defined inside, wherein the wedge chamber (7) includes a clamping wall (7a), the housing channel (9) penetrates the body (5) and communicates with the wedge chamber (7), and the housing channel (9) is suitable for receiving the circular large cable (C) such that a portion of the circular large cable (C) passes through the wedge chamber (7), - A wedge element (11) rotatably connected to the main body (5), - A lever system extending to the outside of the main body (5), suitable for operation by a user to control the rotation of the wedge element (11) in order to change the one-way tightening assembly (1, 3) from the locked configuration to the released configuration, and vice versa, - A wedge element (11) comprising a body (13) substantially located inside the wedge chamber (7), the body (13) having an engaging portion (17) facing the clamping wall (7a) and a control portion (18) facing in the opposite direction to the engaging portion (17), - comprising a pressing means (19) suitable for interacting with the wedge element (11), The one-way clamping assembly (1, 3) is such that the control unit (18) includes an edge (18a'') facing the pressing means (19), and a connecting element (21) exists between the control unit (18) and the pressing means (19), and the connecting element (21) is - When the one-way clamping assembly (1, 3) is in the locking configuration, the edge portion (18a'') is closer to the plane defined by the clamping wall (7a) than to the tangential contact point between the connecting element (21) and the control unit (18), and as a result, the pushing means (19) can bring the engaging portion (17) closer to the clamping wall (7a), - When the one-way clamping assembly (1, 3) is in the release configuration, the edge portion (18a'') is further from the plane defined by the clamping wall (7a) than the tangential contact point between the connecting element (21) and the control unit (18), and as a result, the pushing means (19) can keep the engaging portion (17) away from the clamping wall (7a). A one-way clamping assembly (1, 3) characterized by the following.

2. A one-way clamping assembly (1, 3) according to claim 1, The control unit (18) includes a first control contour (18a') positioned further away from the housing channel (9) than the edge (18a'') and suitable for interacting with the connecting element (21) when the one-way clamping assembly (1, 3) is in the locking configuration, and a second control contour (18a'') positioned closer to the housing channel (9) than the edge (18a'') and suitable for interacting with the connecting element (21) when the one-way clamping assembly (1, 3) is in the release configuration.

3. A one-way clamping assembly (1, 3) according to claim 1 or 2, A one-way clamping assembly (1, 3) in which the pressing means (19) is made in the form of a spring.

4. A one-way clamping assembly (1, 3) according to claim 1, 2, or 3, A one-way clamping assembly (1, 3) in which the connecting element (21) is made in the shape of a sphere.

5. A one-way clamping assembly (1, 3) according to any one of claims 1 to 4, The wedge element (11) is connected to the main body (5) by a connecting pin (15), and the lever system of the wedge element (11) - A closing lever (23) positioned on the same side as the pushing means (19) with respect to the vertical axis passing through the connecting pin (15), - A release lever (25) positioned on the opposite side of the side where the pushing means (19) is located, with respect to the vertical axis passing through the connecting pin (15) and A one-way clamping assembly (1, 3) including the above.

6. A one-way clamping assembly (1, 3) according to any one of claims 1 to 5, One-way clamping assemblies (1, 3) wherein the engaging portion (17) includes knurling suitable for engaging with the circular large cable (C) when the one-way clamping assemblies (1, 3) are in the locking configuration.

7. A tensioning device (10) for a circular large cable (C), comprising one or more unidirectional tightening assemblies (1, 3) according to any one of claims 1 to 6.

8. A tensioning device (10) for a circular large cable (C) according to claim 7, - An elongated body (10a) having a proximal end and a distal end, and a longitudinal axis extending between the proximal end and the distal end, - An operating rod (20) is housed within the elongated body (10a) and slides relative to the elongated body (10a) along the longitudinal axis of the elongated body (10a), - A lever actuator (30) is rotatably connected to the elongated body (10a) and is suitable for controlling the sliding of the operating rod (20) in the first direction (A), - A stopper (50) suitable for preventing the sliding of the operating rod (20) in the second direction (B), - The device comprises a release lever (60) rotatably connected to the elongated body (10a) and suitable for rotating to release the stopper (50) so that the operating rod (20) can slide in the second direction (B), The tension-applying device (10) is characterized by comprising a first one-way clamping assembly (1) according to any one of claims 1 to 7, which is disposed at the distal end of the elongated body (10a), and a second one-way clamping assembly (3) according to any one of claims 1 to 7, which is disposed at the proximal end of the elongated body (10a).

9. A method of applying tension to a circular cable (C) around the bone of a patient, a) The step of attaching the end of the circular large cable (C) to the surgical connector at the surgical site, b) The step of preparing the tension-applying device (10) described in claim 7, c) The step of setting the one-way tightening assembly (1, 3) to the release configuration by operating the lever system of the one-way tightening assembly (1, 3), d) The step of passing the opposite end of the circular large cable (C) through the one-way clamping assembly (1, 3), e) The step of configuring the one-way clamping assembly (1, 3) to the locking configuration by operating the lever system of the one-way clamping assembly (1, 3), f) A step of controlling the sliding of the circular large cable (C) in the first direction (A) relative to the one-way tightening assembly (1, 3) by operating the tensioning device (10) so as to move the end of the circular large cable (C) away from the end of the circular large cable (C). Methods that include...

10. A method for applying tension to a circular large cable (C), a) The step of attaching the end of the circular large cable (C) to the surgical connector at the surgical site, b) The step of preparing the tension-applying device (10) described in claim 8, c) The step of setting the tightening assembly to the release configuration by operating the lever system present in the first one-way tightening assembly (1) and the lever system present in the second one-way tightening assembly (3), d) Passing the opposite end of the circular large cable (C) through the first one-way clamping assembly (1) and the second one-way clamping assembly (3), e) The step of forming the locking configuration of the fastening assembly by operating the lever system of the first one-way fastening assembly (1) and the lever system of the second one-way fastening assembly (3), f) A step of controlling the slide of the operating rod (20) of the tension-applying device (10) by operating the lever actuator (30) of the tension-applying device (10) to move the opposite end of the circular large cable (C) away from the end of the circular large cable (C), thereby increasing the tension of the circular large cable (C). Methods that include...

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