WO2024184364A1

WO2024184364A1 - Ligament tensioning device

Info

Publication number: WO2024184364A1
Application number: PCT/EP2024/055752
Authority: WO
Inventors: Robert Frigg; Jonas WIDMER; Mazda Farshad
Original assignee: Moving Spine Ag
Priority date: 2023-03-06
Filing date: 2024-03-05
Publication date: 2024-09-12

Abstract

The disclosure is directed to a ligament tensioning device (1) for tensioning a ligament (2) entangling at least one component (15) in a patient's body during a surgical intervention. The ligament tensioning device (1) comprises a first holder (3) interconnected to a base (5) and configured to during operation temporarily hold a first end section (6) of the ligament (2). It further comprises a second holder (4) interconnected to the base (5) and configured to during operation temporarily hold a second end section (7) of the ligament (2). At least one of the first holder (3) or the second holder (4) are arranged displaceable with respect to the base (3) and/or each other to tension the ligament (2) entangling the at least one component (15) in a controlled manner. An interaction zone (8) is arranged between the first and the second holder (3, 4) in which the first end section (6) and the second end section (7) of the ligament (2) cross each other in opposite direction longitudinally suitable to be interconnected to each other.

Description

Ligament Tensioning Device

FIELD OF THE DISCLOSURE

The present disclosure relates to a ligament tensioning device for tensioning ligaments in particular allograft or autograft ligaments in the field of semi-rigid spine stabilization and the like.

BACKGROUND OF THE DISCLOSURE

WO21071968A1 was first published in April 2021 on behalf of Ortho Dev Corp. It is directed to a tether tensioning instrument to tension and/or lock a tether about a spinal feature to assist in spinal fixation. The instrument may comprise a handle, a tensioner base coupled with the handle, at least a portion thereof being movably coupled to the handle. A tether coupling member coupled with the tensioner base and configured to fixedly engage a tether. The instrument may further comprise a tensioner tip movably coupled with the tensioner base, wherein at least a portion of the tensioner base is biased away from the tensioner tip. The instrument is configured to allow for step wise movement of the tensioner tip away from the tensioner base to increase tension between the tether and an element of the spinal fixation system.

EP3618743A1 was first published in November 2021 on behalf of Cousin Biotech. It relates to an accessory for tensioning an elongate element for attaching an implant to a bone element. The accessory comprises a device for tensioning the elongate element comprising a drum. The drum comprising a holding portion suitable for cooperating with the elongate element. Said tensioning device comprises a device for rotating the drum about the axis T, allowing the elongate element to be tensioned by winding the elongate element around the drum.

US11344337B2 was first published in August 2019 on behalf of Zimmer Biomed Spine Inc. It relates to devices and systems for attenuation of increased spinal flexion loads post-fusion that include a transition member. The transition member may have a tension component coupleable to a fused vertebra of a plurality of fused vertebra of a fusion implant and to an adjacent unfused vertebra. The tension component may be tensionable to a selected value. The tension component may modulate a flexion range of motion of the adjacent unfused vertebra as a function of the selected value of tension of the tension component. The transition member may attenuate spinal flexion loads on adjacent unfused vertebra post- operatively.

WO16116692A1 was first published in July 2016 on behalf of Implanet. It relates to a device for attaching a flat and flexible band on at least one bone part. The band having two end portions. A rigid base body comprises an opening and a retaining part that can be inserted in the opening. The retaining part is at least partially in the shape of a squeezable wedge comprising a central bore for passage of the end portions facing the flexible band. The bore having a transverse cross-section that can be deformed between a first cross-section for free passage of the end portions when the part has not been inserted in the opening and a second cross-section for locking the end portions by compression when the part is entirely or substantially entirely inserted in the opening. CN204364111 U was first published in June 2015. It relates to a cable tightening device used for tightening a cable. The cable tightening device comprises a barrel, a trigger and a grip. A front barrel body is arranged at the front end of the barrel, a front cable penetrating channel is formed in the front barrel body. The part, in the front cable penetrating channel, of the cable can be locked by a front cable locking mechanism. A front snap ring and a rear snap ring are arranged in the barrel. A mandrel in the barrel is movably supported in a through hole of the front snap ring and a through hole of the rear snap ring and extends out of the barrel. The cable tightening device can be operated with one hand.

W010141086A1 was first published in December 2010 on behalf of Kinamed Inc. It is directed to a surgical cable tensioning system. It includes a reaction frame which contains a sliding platform arranged to move linearly within the frame. A clam-type cleat is attached to the sliding platform. The cleat features one or more grooves, each of which comprises two arrays of opposing ridges that converge to form a V-shape groove adapted to receive a length of cable. The ridges of each groove are tilted relative to an axis perpendicular to the groove's longitudinal axis, such that the cable is progressively captured between the ridges of the opposing arrays as it settles into the crotch of the groove when moved in a first direction. It can be disengaged from the cleat by relaxing the axial force on the cable and moving it in the opposite direction. A linear actuator mechanism may be coupled to the sliding platform to move the platform with respect to the reaction frame.

WO06118259A1 was first published in November 201 1 on behalf of Alfresa Pharma Corp. It relates to a cable-tightening device. The device comprises a grip portion, a rod-like member extending forward, a knot-supporting means at the tip, a cable-holding means to grip and hold the tow arms together, and a sliding block mounted around the rod-like member and connected to a pulling means. Further it comprises an operation lever to drive the pulling means.

US6582433B2 was first published in October 2022 on behalf of Kyphon Sari. It relates to a device and method that immobilizes the vertebral bodies by immobilizing the respective spinous process extending therefrom. The device contains a spacer extending from a body with the spacer adapted to be positioned between adjacent spinous processes so that the spacer may be located close to the spine. A strap connected with the body is designed to engage the spinous processes, such that the device may be adjusted to be positioned about the spinous processes. The device ensures that the spacer remains positioned between adjacent spinous processes. The method to insert the device minimizes destruction to body tissue, thus it is less traumatic to the patient and allows for the patient to recover from the procedure faster than conventional methods.

W09401057A1 was first published in January 1994 on behalf of Erpios Snc. It relates to a prosthesis including a flexible ligament with a first narrowed thinner portion and a second wider portion forming an extension of and having a greater width and thickness than the first portion which portion may be passed around the spinous processesof two adjacent vertebrae in a figure eight pattern. The second portion circles around the processes in a semi-flexible interprocess block with two pairs of through-channels. SUMMARY OF THE DISCLOSURE

According to the prior art, spinal fusion by rigid metal rods attached to several vertebrae by screws to stabilizing them and if necessary insertion of intervertebral cages is at presence a very common surgical procedure, among others in the treatment of degenerative disorders of the spine. However, spinal fusion is often associated with serious long-term complications such as adjacent segment degeneration, screw loosening, pseudo arthrosis, implant failure, and, in rare cases, neurovascular injury during implant insertion. Negative redistribution of loads with subsequently increased biomechanical stress are believed to act as accelerators of adjacent segment disease and proximal junctional kyphosis. Further, long fusions can lead to a relevant, irreversible loss of motion, which can cause postural changes. Although these challenges are well known, alternative techniques of spinal stabilizations have not yet yielded satisfactory results with broad clinical impact. Since about twenty years, a variety of semi-rigid fixation techniques has been proposed to overcome the above-mentioned challenges, but resulted in new complications at the implant-bone interface such as device breakage, dislocation or screw loosening.

The above problems are successfully addressed in a particular way by a new method of soft spinal stabilization by posterior implementation and fixation of strap like implants in a manner, which does not negatively affect the biomechanics. The strap like implants are preferably in the form of ligaments, preferably autograft or allograft ligaments or artificial ligaments or a combination thereof. It is understood that this also includes xenograft ligaments, as well as implants in the form tendons, including autograft, xenograft allograft tendons or artificial tendons. Good results can be achieved, when the implants are arranged in at least one closed loop or a series of parallel and/or intersecting loops entangling two spaced apart components of the skeleton in a patient’s body and are then pretensioned in specific manner before being affixed. The component of the skeleton may e.g. be a vertebra or a rib. If the at least one loop entangles two or more of the same or different components, influence is taken on the resulting load path and load distribution. One difficulty, which occurs with this method is, that the implants which preferably are having a particular stress-strain characteristics, should be installed under an initial tension to bring the operating point of the resulting mechanical system to a defined value. The devices and systems known from the prior art do not offer appropriate measures.

With the ligament tensioning device according to the present disclosure, it becomes possible to adjust the biomechanics of the interaction of the implant and the skeleton such that the resulting mobility is close to the natural behavior. The ligament tensioning device according to the present disclosure, allows the application and fixation of an implant in a controlled and gentle manner while the implants are under a specific tension. This is advantageous with respect to load distribution and thereby reduces the problems inherent to the prior art. It has been found that it is of particular importance, that the load level is chosen in biome- chanically appropriate manner. The devices according to the present disclosure are optimized to process natural ligaments and/or artificial ligaments that have similar properties as they offer an interaction zone in which a first end section and the second end section of a ligament may cross each other and/or may be de- fleeted with respect to each other in opposite direction longitudinally. The deflection may result from a deflection of the ligament with respect to itself, respectively each other, when more than one is present, or e.g. by an additional retainer which acts as a linking element. Good results may be achieved when the retainer is ring shaped. In difference to the prior art the ligament is not mechanically disadvan- tageously stressed. The interconnection in the interaction zone can be established in a gentle and ligament correct manner which improves the ingrowth, durability and healing of the tissue.

In a preferred variation, a ligament tensioning device for tensioning an implant preferably comprises a first holder and a second holder. The first and the second holder are interconnected to a base and configured to during operation temporarily hold a first end section, respectively a second end section of a strap like implant, e.g. in the form of a ligament or an extension attached to or forming part of the ligament in the form of a cord which can be removed at a later stage when not needed any more. Usually at least one of the first holder or the second holder is arranged displaceable with respect to the base and/or each other to, during the surgical intervention, tension the ligament entangling the at least one component of the skeleton in a controlled manner by relative displacement until a desired force level is reached. The ligament tensioning device according to the disclosure further comprises an interaction zone in which during operation the first end section and the second end section of the ligament cross each and/or are redirected with respect to each other in opposite direction longitudinally, suitable to be interconnected to each other in the area of crossing and/or pass through a retainer (fastener) by which they can be interconnected to each other indirectly. Depending on the field of application, the ligament tensioning device may comprise at least one idler in the direction of the ligament usually arranged before at least one of the first or the second holder. The at least one idler redirects the ligament during operation and feeds it to the holder. The ligament tensioning device preferably comprises a dynamometer to determine the total force applied to the ligament in the area of the interaction zone. Furthermore, the dynamometer may be configured to precisely indicate the total force on a scale and/or comprise a force limiter, which limits the force applied to the ligament to a certain level. The force limiter may be fixed or adjustable, if appropriate. Good results can be achieved when the force limiter comprises an overload clutch that disengages when the force applied to the ligament reaches a predetermined level. Depending on the field of application, the overload clutch preferably disengages at a force level in the range of 40N to 100N, more particular at a force level in the range of 60N to 80N, more particular in the range of 65N to 75N. In some applications, the overload clutch may disengage at a force level in the range of 40N to 250N, more particular at a force level in the range of 60 N to 200 N. Depending on the field of application, the ligament tensioning device may comprise a linear guide device and/or a rotation guide device or a combination thereof, by which the first and the second holder can be displaced relative to each other and/or relative to the base to tension the ligament during process. For versatile application, the ligament tensioning device can be designed such that the length of the interaction zone is adjustable.

Depending on the application, the ligament tensioning device may optionally further comprise a third holder interconnected to the base and configured to during operation temporarily hold a ligament connector for interconnecting the first end section and the second end section of the ligament in the interaction zone. For example, the ligament connector may optionally be releasably engaged with the third holder before the operation. During the operation, the ligament connector may then be interconnected to the first end section and the second end section of the ligament in the interaction zone. In some variants, the third holder may be arranged between the first holder and the second holder or, if present, between the idlers.

Depending on the application, the third holder may further be configured to during operation temporarily hold one or more suture carriers each comprising an opening for holding at least one suture forming a plurality of loops for encompassing the first end section and/or the second end section of the ligament. In some variants, the one or more suture carriers may be separate pieces, e.g. separate from the ligament tensioning device. Optionally, the one or more suture carriers may be releasably engageable with the third holder. It is understood that the suture may for example comprise a surgical suture, but it may also comprise a cord or string.

In some variants, the ligament tensioning device further comprises a tensioning unit for activating during operation the ligament connector, such that the first end section and the second end section of the ligament are interconnected in the interaction zone. Different modes of activation may be used. For example, the ligament connector may be activated through tensioning. Optionally, in some variants, the ligament tensioning device may further comprise a suture separator for cutting the at least one suture after interconnection to the first end section and the second end section of the ligament in the interaction zone. It is understood that, depending on the application, the ligament tensioning device may be provided together with or separately from the at least one suture that forms a plurality of loops for encompassing the first end section and/or the second end section of the ligament. Thus, in some variants, the ligament tensioning device comprises the at least one suture forming a plurality of loops. The plurality of loops may for example be arranged displaceable with respect to the one or more suture carriers. Depending on the application, different carriers may be used. For example, in some variants, the carrier has a bore for receiving the at least one suture and for receiving the first end section and/or the second end section of the ligament. Alternatively or in combination, the carrier may have different shapes. For example, the carrier may be tubular. Alternatively or in combination, the carrier may have a C-shaped cross section and may comprise a slit extending in longitudinal direction of the carrier. Alternatively or in combination, the carrier may comprise a predetermined breaking point.

Depending on the application, the third carrier may comprise one or more carriers. For example, in some variants, the third carrier comprises a first suture carrier for holding a first suture forming a plurality of loops for encompassing the first end section of the ligament, and the third carrier further comprises a second suture carrier for holding a second suture forming a plurality of loops for encompassing the second end section of the ligament.

It is to be understood that both the foregoing general description and the following detailed description present embodiments, and are intended to provide an overview or framework for understanding the nature and character of the disclosure. The accompanying drawings are included to provide a further understanding, and are incorporated into and constitute a part of this specification. The drawings illustrate various embodiments, and together with the description serve to explain the principles and operation of the concepts disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS The herein described disclosure will be more fully understood from the detailed description given herein below and the accompanying drawings which should not be considered limiting to the disclosure described in the appended claims. The drawings are showing:

Fig. 1 a first variation of a ligament tensioning device according to the pre- sent disclosure in a perspective view from the front and above;

Fig. 2 the first variation of a ligament tensioning device according to Figure 1 in a perspective view from the behind and above;

Fig. 3 the ligament tensioning device according to Figure 1 in a partially cut view in an untensioned, retracted position; Fig. 4 the ligament tensioning device according to Figure 1 in a partially cut view in a tensioned, extended position;

Fig. 5 Detail A according to Figure 4;

Fig. 6 A second embodiment of a ligament tensioning device in a perspective view from above and the front; Fig. 7 The ligament tensioning device according to Figure 6 in a perspective view from above and behind;

Fig. 8 The ligament tensioning device according to Figure 1 in a perspective view from the front and above, including a retainer;

Fig. 9 A third embodiment of a ligament tensioning device in a perspective view from above and the front.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to certain embodiments, examples of which are illustrated in the accompanying drawings, in which some, but not all features are shown. Indeed, embodiments disclosed herein may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Whenever possible, like reference numbers will be used to refer to like components or parts.

Figure 1 shows a ligament tensioning device 1 according to the present disclosure in a perspective view from above and the front. Figure 2 is showing the ligament tensioning device 1 in a perspective view from the rear and above. Figure 3 is showing the ligament tensioning device according to Figure 1 in a partially cut view in an untensioned, retracted position. Figure 4 is showing the ligament tensioning device according to Figure 1 in a partially cut view in a tensioned, extended position. Figure 5 is showing detail A according to Figure 4. Figure 6 is showing a second embodiment of a ligament tensioning device 1 in a perspective view from above and the front. Figure 7 is showing the ligament tensioning device according to Figure 6 in a perspective view from above and behind. Figure 8 shows a ligament tensioning device 1 according to Figure 1 in a perspective view from the front and above, including a retainer 40. Figure 9 shows a third embodiment of a ligament tensioning device 1 in a perspective view from above and the front.

During a surgical intervention, a ligament 2 e.g. is arranged such that it entangles two components of the skeleton 15 in a patient’s body. The components 15 can e.g. be vertebrae or the like, which are spaced apart by a distance and shall be interconnected to each other in a biomechanically preferably manner. Good results can be achieved with a ligament tensioning device 1 which comprises a first holder 3 interconnected to a base 5 and configured to during the intervention temporarily hold a first end section 6 of a ligament 2. In the drawings is shown in a simplified manner as line. The ligament tensioning device 1 further comprises a second holder 4 interconnected to the base 5 and configured to hold a second end section 7 of the ligament 2.

In the shown variation, the first holder 3 and the second holder 4 are arranged at the end of a first and a second cantilever 16, 17. While the first cantilever 16 is fixedly arranged at a primary guide rod 18 of the base 5, the second cantilever 17 is arranged at a bracket 19 encompassing the primary guide rod 18 and being linearly displaceable along the primary guide rod 18 in an axial direction (x). The bracket 19 comprises an internal thread 20, which is the mounted position engaged with an external thread 21 of a bushing 22. The bushing 22 is rotatable around a rotation axis 30 and in the shown variation, displaceable with respect to the guide rod 18. The bracket 19 is arranged in a non-rotatable manner but linear displaceable with respect to the guide rod 18. A secondary guide rod 31 is fixedly arranged parallel to the primary guide rod 18. It is engaged with a corresponding bore 32 of the bracket 19 and thereto in longitudinal direction thereto displaceable. Thereby it prevents unwanted rotation between the bracket 19 and the primary guide rod 18.

The bushing 22 is supported with respect to the guide rod 18 by a first helical spring 23 which, when the first and the second holder 3, 4 are displaced apart from each other in the axial direction (x) by relative rotation of the internal thread 20 with respect to the external thread 21 exceeds a force against the resistance of the ligament 2 interconnected via the first and the second holder 3, 4 to the ligament tensioning device 1 . The rotation is initiated by a knob 24 which is interconnected to the external thread by an overload clutch 25, which acts as a force limited in that it disengages when the force applied to the ligament 2 via the spring 23, exceeds a predefined maximum. In the shown variation, the overload clutch comprises a clutch pin 26 which when engaged - as visible in Figure 3 - is arranged in a first slot 27 of the bushing 22 and simultaneously in a second slot 28 of the knob 24 and thereby mechanically engages them to each other in direction of rotation. The clutch pin 26 extends transversely with respect to the first direction (x). It is supported in axial direction by a second helical spring 29 that is arranged inside the knob 24 in a precompressed manner and pushes the pin 26 in the direction of the first spring 23 away from the knob 24. A release pin 33 arranged at the primary guide rod 18 pushes against the clutch pin 26 corre- spending to the compression of the first helical spring 23. When a certain predetermined load level is reached, which is corresponding to the axial compression of the first helical spring 23 due to the external force exerting on the ligament 2, the knob 24 is disengaged from the bushing 22 in the direction of rotation, as the clutch pin 26 is lifted out of one of the second slot 28 as visible in Figure 4 an in even more detail in Figure 5 in which the hidden lines are displayed, such that the position of the disengage pin is visible. If requested the overload clutch can be designed with an adjustable load level for more flexibility. Depending on the load level to be achieved the overload clutch 25 disengages at a force level in the range of 40N to 100N, more particular at a force level in the range of 60N to 80N, more particular in the range of 65N to 75N. Depending on the field of application, other values may be appropriate.

In the variation according to Figures 1-5, the first and the second holder 3, 4 are arranged at the end of the first cantilever and the second cantilever 16, 17. Thereby it becomes possible to place the ligaments close to the structure of the patient. As it can be seen in the drawings, the first and the second holder 3, 4 are spaced a first distance 13 apart from each other defining a length of an interaction zone 8 in which during operation the first end section 6 and the second end section 7 of the ligament 2 may cross each other in opposite direction longitudinally and/or may be deflected with respect to each other, if appropriate by a retainer 40 as schematically shown in Figure 8. The interaction zone 8 is preferably dimensioned in a manner that the first and the second end section 6, 7 of the ligament 2 closely approximate each other. The tension on the ligaments can be adjusted by the linear guide device 14. When the optimum tension level is reached, the opposite end sections 6, 7 of the ligament 2 can be laterally interconnected to each other. In a preferred variation, the length of the interaction zone 8 is adjustable before tension is exerted onto the ligament 2.

The variation of the ligament tensioning device 1 according to Figure 6 and Figure 7 is now explained in more details. With respect to the general description and functionality, reference is made to Figures 1-4. The ligament tensioning device 1 comprises a base 5 from which a first and a second cantilever 16, 17 extend perpendicular. While a first holder 3 is arranged at the first cantilever 16 in a non-displaceable manner, a second holder 4 is arranged in a linearly displaceable manner at the second cantilever 17. Each cantilever 16, 17 comprises at its free end an idler 9 by which during operation a ligament 2 can be redirected (deflected) in the direction of the first, respective the second holder 3, 4 after extending across an interaction zone 8. The interaction zone 8 of the present variation is, in difference to the first variation according to Figures 1-5, arranged between the two idlers 9. The idlers 9 can be arranged rotatably to reduce friction. The first and the second end sections 6, 7 of the ligament 2 are attached to the holders 3, 4 while they entangle two components of a skeleton as mentioned herein above. As illustrated, the holders 3 and 4 each comprise a clamp 34 with two opposite clamp jaws 35 between which the respective first and second end sections 6, 7 of the ligament 2 are clamped. By a threaded spindle 38 that is interconnected to the second holder 7, the second holder 7 can be displaced along the second cantilever 17. Thereby the ligament can be tensioned. As schematically shown, the ligament tensioning device 1 comprises an integrated dynamometer by which the tension force exerted onto the ligament 2 in the interaction zone 8 can be displayed on a scale 39. As is also illustrated in Figure 6, the first holder and the second holder may for example be arranged such that during operation the first end section and the second end section of the ligament extend essentially in parallel to each other in the interaction zone.

The variation of the ligament tensioning device 1 according to Figure 9 is now explained in more detail. The variation of Figure 9 is substantially similar to the variation of Figures 6 and 7, and therefore reference is made to Figures 6 and 7, in particular with respect to the general description and functionality. In contrast to the embodiment in Figures 6 and 7, the embodiment shown in Figure 9 additionally comprises a third holder 41 arranged between the two idlers 9. The third holder 41 is connected to a suture carrier 42, which has a C-shaped cross-section and is arranged in the interaction zone 8. The suture carrier 42 comprises an opening for receiving the first end section 6 and the second end section 7 of the ligament 2. The opening of the suture carrier 42 is also configured for holding a suture forming a plurality of loops (not shown), which may be used for interconnecting the first end section 6 and the second end section 7 in the interaction zone. For example, the suture may form a first hitch and a second hitch, wherein the first hitch may during operation encompass the first end section and the second hitch may during operation encompass the second end section. Furthermore, the embodiment shown in Figure 9 also comprises a tensioning unit 43 for tensioning during operation the suture that interconnects the first end section and the second end section of the ligament.

Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the Spirit and scope of the disclosure. LIST OF DESIGNATIONS

1 Ligament tensioning 20 Internal thread device 21 External thread

2 Ligament 22 Bushing

3 First holder 23 First helical spring

4 Second holder 30 24 Knob

5 Base 25 Overload clutch

6 First end section 26 Clutch pin (overload

7 Second end section clutch)

8 Interaction zone 27 First slot

9 Idler 35 28 Second slot

10 Dynamometer 29 Second helical spring

11 Scale 30 Rotation axis

12 Force limiter 31 Secondary guide rod

13 Distance between 32 Bore (bracket) holder 40 33 Release pin (overload

14 Linear guide device clutch)

15 Component (of the 34 Clamp (holder) skeleton) 35 Clamp jaw (holder)

16 First cantilever (base) 36 Wedge (holder)

17 Second cantilever 45 37 Handle

(base) 38 Threaded spindle

18 Primary guide rod 39 Scale (base) 40 Retainer (ligament)

19 Bracket 41 Third holder 42 Suture carrier 43 Tensioning unit

Claims

PATENT CLAIMS

1. Ligament tensioning device (1 ) for tensioning a ligament (2) entangling at least one component (15) in a patient’s body during a surgical intervention, comprising: a. a first holder (3) interconnected to a base (5) and configured to during operation temporarily hold a first end section (6) of the ligament (2); b. a second holder (4) interconnected to the base (5) and configured to during operation temporarily hold a second end section (7) of the ligament (2); wherein c. at least one of the first holder (3) or the second holder (4) are arranged displaceable with respect to the base (3) and/or each other to tension the ligament (2) entangling the at least one component (15) in a controlled manner; d. an interaction zone (8) in which during operation the first end section (6) and the second end section (7) of the ligament (2) cross each other and/or are deflected with respect to each other in opposite direction longitudinally, such that the first end section (6) and the second end section (7) of the ligament (2) can be interconnected to each other under a predetermined tension.

2. The ligament tensioning device (1 ) according to claim 1 , comprising a dynamometer (10) to determine the total force applied to the ligament (2) in the area of the interaction zone (8).

3. The ligament tensioning device (1 ) according to claim 2, wherein the dynamometer (10) indicates the total force on a scale (1 1 ) and/or comprises a force limiter (12) which limits the total force applied to the ligament (2) to a certain force level.

4. The ligament tensioning device (1 ) according to claim 3, wherein the force limiter (12) comprises an overload clutch (25) which disengages when the force applied to the ligament (2) reaches a predetermined level.

5. The ligament tensioning device (1 ) according to claim 4, wherein the overload clutch (25) disengages at a force level in the range of 40N to 100N, more particular at a force level in the range of 60N to 80N, more particular in the range of 65N to 75N.

6. The ligament tensioning device (1 ) according to any of the preceding claims, wherein the ligament tensioning device (1 ) comprises a linear guide device (14) and/or a rotation guide device by which the first and the second holder (3, 4) can be displaced relative to each other and/or relative to the base (5).

7. The ligament tensioning device (1 ) according to any of the preceding claims, wherein the length of the interaction zone (8) is adjustable.

8. The ligament tensioning device (1 ) according to any of the preceding claims, wherein the interaction zone (8) is arranged between the first and the second holder (3, 4).

9. The ligament tensioning device (1 ) according to any of the preceding claims, wherein with respect to the general direction of the ligament (2), between the first and the second holder (3, 4) at least one idler (9) is arranged which redirects the ligament (2) in a controlled manner.

10. The ligament tensioning device (1 ) according to claim 9, wherein the at least one idler (9) is arranged laterally with respect to the first and the second holder (3, 4).

1 1 . The ligament tensioning device (1 ) according to claim 9 or 10, wherein the distance between the at least one idler (9) and the first, respective the second holder (3, 4) is adjustable.

12. The ligament tensioning device (1 ) according to any of the claims 9 through 1 1 , wherein the at least one idler (9) is arranged rotatable to reduce friction.

13. The ligament tensioning device (1 ) according to any of the preceding claims, wherein the first and the second holder (3, 4) each comprise at least one clamp (34) with two opposite clamp jaws (35) between which the ligament (2) can be clamped during processing and/or at least one wedge (36) in which the ligament (2) can be wedged during processing or a combination thereof.

14. The ligament tensioning device (1 ) according to any of the preceding claims, further comprising a third holder (41 ) interconnected to the base (5) and configured to during operation temporarily hold a ligament connector for interconnecting the first end section (6) and the second end section (7) of the ligament (2) in the interaction zone (8).

15. The ligament tensioning device (1 ) according to claim 14, wherein the third holder (41 ) is arranged between the first holder (3) and the second holder (4) or, if present, between the idlers (9).

16. The ligament tensioning device (1 ) according to claim 14 or 15, wherein the third holder (41 ) is configured to during operation temporarily hold one or more suture carriers (42) each comprising an opening for holding at least one suture forming a plurality of loops for encompassing the first end section (6) and/or the second end section (7) of the ligament (2).

17. The ligament tensioning device (1 ) according to any of claims 14-16, further comprising a tensioning unit (43) for activating during operation the ligament connector, such that the first end section (6) and the second end section (7) of the ligament (2) are interconnected in the interaction zone (8).