Orientation device for tibial resection guidance

Abstract

The invention relates to a targeting device for tibial resection guidance, comprising a clamping device with at least two clamping elements acting on one another for clamping a distal portion of a tibia of a patient, a contact device for contacting a proximal portion of the tibia, the contact device comprising a tool guiding device for guiding a tool during tibial resection, and a telescoping device which is detachable from the contact device and which is adjustably connected to the clamping device and which is configured to orient the device relative to the tibia, wherein the telescoping device additionally has a decoupling device in its proximal region, which is configured to detach the contact device from the telescoping device when activated, and the clamping elements of the clamping device are configured such that the telescoping device can be removed from the tibia with one hand after the decoupling device has been activated.

Description

Technical Field

[0001] This disclosure relates to a directional device or directional aid for guiding tibial resection, the directional device or directional aid including a clamping device having at least two clamping elements interacting for clamping the distal end of the patient's tibia; the directional device or directional aid including a contacting device for contacting the proximal end of the tibia, the contacting device including a tool guiding device for guiding the tool during tibial resection; and a telescopic device detachable from the contacting device and adjustablely connected to the clamping device, the telescopic device being configured to orient the device relative to the tibia. Background Technology

[0002] For successful joint prosthesis implantation surgery, precise resection of the patient's bone, especially the tibia, is of great significance. The plane of resection must be precisely positioned to minimize the amount of bone removed while simultaneously ensuring the removal of all defective bone tissue. The comparison of the plane with respect to the anatomical axes, particularly the tibial axis, must be continuously controlled during the surgery to ensure the orientation of the joint surfaces throughout the entire range of joint movement.

[0003] Precise determination of the tibial resection plane in the knee joint is typically achieved using a directional device or a guide with a cylindrical setting bar (for sawing blocks) or a telescopic device secured near the ankle, away from the tibia. Here, the telescopic device extends along the tibia (basically) parallel to the anatomical tibial axis. Thus, the resection plane can be defined relative to the tibial axis. A tool guide, secured to the directional device, ultimately defines the resection plane. Typically, the tool guide has a through-slit through which the reciprocating, pivoting, flat blade of the surgical instrument (saw) passes.

[0004] To orient the tibial resection plane, an orienting device is installed on the tibia. This orienting device is connected to a telescopic device at its end pointing towards the patient's foot, and a tool guide device is connected to its other end (end section). Here, the distinction is essentially between two orienting and fastening principles, namely "anterior fixation" and "proximal fixation." In "anterior fixation," the orienting device is fastened solely by the aforementioned foot cuff / bone cuff, while in "proximal fixation," an additional impact pin is provided on the proximal end section of the orienting device, which is hammered into the so-called intercondylar eminence of the tibia. Background Technology

[0006] US 6,221,035 B1 discloses a foot cuff / bone cuff in the form of a fixation clamp of an anterior fixation structure type for use in tibial resection. Here, the fixation clamp is arranged at the distal end section of a retractable directional rod, at which a tibial cutting block is mounted.

[0007] The clamp itself has two spring-preloaded clamping arms that can rotate about a rotation axis relative to the frame. These clamping arms are brought into the open position and, after abutting against the tibia, are released by a manual triggering device. Due to the spring preload, the clamping arms then surround and clamp the ankle or tibia. Here, the clamping arms are preloaded in the closing direction / around the clamping direction. The spring preload causes the directional aid to be forcefully secured to the ankle or directly above the ankle; however, this has the disadvantage that hematoma may occur in the patient at the relevant body part due to the clamping force.

[0008] The clamping arms apply a spring-loaded force to the ankle joint or bone. However, the fixation clamp is not adapted to the patient's anatomy, resulting in varying clamping forces applied by the clamping arms based on the shape of the foot / leg and the thickness of the ankle. This also results in a retaining force of the fixation clamp that is related to the shape of the ankle joint.

[0009] Furthermore, for example, US 7,344,542 B2 discloses a tibial orientation guide of the proximal fixation structure type, wherein a crossbeam is rigidly connected to a retractable main rod at its proximal end section. A fastening pin is supported on the free end section of the crossbeam, the fastening pin being hammered into the tibia for additional fixation of the orientation aid, wherein a lever is also supported on the crossbeam, which presses against the tibia during manipulation to pull the pin held on the crossbeam out of the tibia. This means that the entire crossbeam with integrated pins is pried out relative to the bone, wherein the connection between the tibial cutting block or saw and the vertical main rod must be unfavorably released simultaneously.

[0010] Finally, a surgical screw extractor is basically known from US 2010 / 0087831 A1, which can grasp under the screw head and pull the screw head out of the bone by means of levers and transmission mechanisms.

[0011] The above-mentioned types of tibial orienting aids / devices have fundamental problems, especially regarding their operation:

[0012] Therefore, it is necessary, for example, to provide directional aids with different designs for the two fastening principles mentioned above. This is expensive and complicates the entire operation process (including storage, sterilization, etc.).

[0013] - In addition, directional aids are often removed from the patient's leg during surgery. For this reason, traditional directional aids always require multiple handles / actions based on the fastening principle, for example, to loosen the distal and / or proximal fasteners.

[0014] - It is also important to remember that body dimensions are patient-specific and significantly different from one another. Traditional orientation aids for known structural types, through their respective setting possibilities, only cover a limited range of deviations. This means that, using known systems, it is impossible to individually operate on the full length range of the tibia worldwide; instead, multiple systems / orientation aids with potentially overlapping length ranges must be maintained, leading to the aforementioned problems regarding cost and complex procedures. To set varus / valgus alignment, the initially coarsely set length of the retractable rod / main bar must always be actively (manually) secured to prevent misalignment. That is, for subsequent fine correction of the length setting, it is always necessary to operate (e.g., temporarily manually partially release) the fixation mechanism that should normally be fixed at the coarsely set length.

[0015] Another problem with existing techniques is that fixation at the patient's bone is typically force-fitted, or the clamping arms are force-fitted pre-tightened, resulting in insufficient positionability due to the inherent elasticity of the clamping arms. Adaptation to the patient's anatomy is not achieved. In the worst case, this leads to detachable fixation, which is insufficient due to the high requirements for dimensional stability or the precision of the orientation of the resection plane as described at the beginning. Furthermore, hematomas may occur at the patient's body sites due to varying clamping forces in elastically pre-tightened clamping arms.

[0016] - Fixation clamps known by existing technology cannot cover all anatomical dimensions because the clamping force depends on the patient's corresponding anatomical structure. Therefore, different variations of fixation clamps for orthopedic devices must be manufactured and prepared for optimal fit; however, this is impractical due to high cost and poor operability. A problem with fixation clamps for orthopedic devices that are spring-loaded and abut against the ankle joint or bone is that different clamping forces are applied by the springs depending on the foot shape and ankle thickness. Summary of the Invention

[0017] Therefore, the fundamental objective of this invention is to at least partially avoid or at least reduce the aforementioned disadvantages of the prior art, and in particular to provide a (tibial) orientation device capable of efficient operation, particularly simple, reliable, and rapid fixation of the patient's hands / feet / limbs / lower legs, and simple and rapid disengagement of the fixation. Preferably, the orientation device is adapted to or adaptable to different anatomical structures of the hands / feet, and preferably can be used for each anatomical structure while minimizing hematoma through its mode of operation and configuration. The orientation device should also preferably have the simplest possible structure, which can be easily installed, cleaned, and sterilized if necessary. Overall, the cost associated with the operation of this type of orientation device or orientation aid should also be kept as low as possible. Finally, the orientation device should preferably be as flexible in application as possible.

[0018] This task is solved according to the orientation device / orientation aid of the present invention.

[0019] The orientation device according to the invention (“extramedullary tibial orientation system”) is / forms an extramedullary orientation system, particularly for the proper execution of proximal tibial cuts in total or unicompartmental knee arthroplasty (TKA / UKA). The orientation device is essentially used to orient saw blocks of proximal tibial cuts, as known in the art, on corresponding landmarks of the tibia according to clinical requirements and the surgeon’s intention, and to achieve sufficient stability when securing the saw blocks to the anterior epiphyseal region of the tibia. Furthermore, if required by the surgeon, the orientation device should ensure sufficiently high stability even during bone sawing using the saw blocks by selectively fixing the orientation device to, for example, the tibia.

[0020] This system, or the orientation device according to the invention, satisfies two different orientation and fastening principles as required by the user within a unit. These are referred to below as "anterior fixation" and "proximal fixation." As defined above, they are named according to their primary fixation possibilities. According to the invention, the "proximal fixation" type is preferably achieved by placing an additional "proximal fixation unit" (adapter-like) on the "anterior fixation" type and thereby additionally achieving proximal fastening on the "tibial intercondylar eminence." In "anterior fixation," primary fixation in the proximal region is achieved (according to standard) by means of a pin placed in the "tibial tuberosity" through an elongated hole in the saw block.

[0021] The following parameters are set or oriented using the orientation device according to the invention:

[0022] ο Inward / outward cutting angle.

[0023] ο Flexion / extension cutting angle (posterior / anterior cutting angle or dorsal / ventral cutting angle (slope)).

[0024] ο Proximal cutting height ( (Desired bone cut thickness).

[0025] The orientation device according to the invention is essentially composed of the following individual components that are individually claimable, and these components may be further investigated within the scope of the divisional application if necessary:

[0026] • Remote holding clamps, especially foot clamps

[0027] The distal retaining clamp (hereinafter referred to as the foot clamp only by example) is located at the distal end of the orientation device according to the invention. The distal retaining clamp performs the following functions:

[0028] The orienting device is maintained and stabilized within the ankle joint region in terms of lateral and rotational movements relative to the tibia (or relative to the anatomical tibial axis and therefore generally also relative to the mechanical tibial axis).

[0029] ο Orienting the orientation device relative to the distal marker

[0030] 1. The distal anterior ankle joint center

[0031] 2. The distal anterior tibial ridge

[0032] The following parameters are settable:

[0033] 1. Inward / outward cutting angle

[0034] 2. Front / back cutting angle (slope)

[0035] Simply and invasively remove the orientation device from the patient's leg.

[0036] Increase / decrease the length range of the orientation device

[0037] ·handle

[0038] The (retractable) handle preferably consists of a slide bar and a handle. These two components are telescopically connected to each other. The handle connects the distal instrument part (foot clamp) to the proximal instrument part (saw block, adapter for the saw block if necessary, and / or fastening arm of the type with proximal fastening).

[0039] In addition, the handle also fulfills the following functions:

[0040] The handle supports the orientation of the orientation device with respect to all three parameters mentioned above. This is done by visually and / or tactilely referencing the handle relative to the anterior tibial ridge by simultaneously pressing the anterior tibial ridge (with the index, middle, and thumb fingers) and the anterior handle ridge (with the palm between the index finger and thumb fingers).

[0041] The handle preferably includes a fixing unit (e.g., a manual screw with a spring-loaded clamping element) for fixing the orientation device at a set orientation height. Here, in the "front-fixed" type, the orientation device height is set solely through this function. For the "proximal-fixed" type, a vertically movable, self-adaptive slide is preferably also present, on which a sawing block can be mounted or mounted.

[0042] Another function of the fixing unit is to ensure the initially estimated and not yet finalized height setting during orienting of the orienting device. This is achieved through self-locking, for example, by means of a spring-loaded pin in the fixing unit, which presses against the handle portion at the distal end of the orienting device. This allows the user to simultaneously correct for inversion / eversion, rotation, and height orientation. The configurable self-attachment prevents the orienting devices from sliding together due to gravity, thus reducing handling and time consumption, and therefore positively impacting surgical time and consequently the surgical team and patient.

[0043] The fixed unit can be implemented in different schemes.

[0044] 1. A solution with clamping and self-adhesive sliding functions, or

[0045] 2. It has clamping function, self-adhesive sliding function, and can fall freely.

[0046] (Free fall) function

[0047] • Adapter for securing saw blocks to the handle

[0048] The preferred saw block adapter is located near the end of the orientation device (especially the handle) and has the following functions.

[0049] ο To accommodate tibia saw cuts for the right or left leg.

[0050] The free-sliding arrangement on the handle works particularly well with the "proximal fixation" type used for final cutting height setting. Free-sliding can also be considered in the "front fixation" type, especially when the adapter is initially fixed in the middle position. This allows for simpler height correction after the locking unit is in place.

[0051] • Proximal fixation unit

[0052] The selectively arranged "proximal fixing unit" basically consists of a horizontal cantilever and a vertical support. The "proximal fixing unit" or vertical support can be selectively installed on the proximal end of the handle in a "front-fixed" type. It has the following functions:

[0053] Simple fixation and release of the "proximal fixation unit" in the proximal shank of the "anterior fixation" type.

[0054] When there is no external force, even a small thrust, the horizontal mobility of the cantilever within the strut provides self-attachment if necessary. This mobility of the cantilever ensures compatibility with tibial anatomy worldwide, allowing the user to set the incline at any time.

[0055] By using two preferred impact pins, rotation and lateral displacement are prevented by fixing them to the intercondylar process of the tibia.

[0056] Use an impact rod to loosen the pin.

[0057] Guide the saw block adapter during cutting height setting.

[0058] • Configurable cutting height detector

[0059] The cutting height detector can be selectively installed on the proximal tibial saw block and is basically composed of the following components:

[0060] ο Adapter interface for tibial saw blocks with locking and release mechanisms

[0061] ο Self-locking sliding probe arm with a probe tip

[0062] ο Unit for height adjustment

[0063] The configurable cutting height detector has the following functions:

[0064] The cutting height detector is easy to install and remove on the tibia saw block.

[0065] Use the probe tip to detect bone landmarks. The landmarks selected by the user are references against which the cutting height is set.

[0066] The horizontal mobility of the height detector adapts to different anatomical structures of the tibial epiphysis and reaches the medial and lateral tibial condyles from the same adapter site.

[0067] Setting the cutting height

[0068] • Proximal tibia sawed block

[0069] Preferably, there are different variations of the tibial sawing block. These variations differ in the following characteristics:

[0070] It can be used on the right and left tibias.

[0071] It is compatible with both "anterior fixation" and "proximal fixation" types.

[0072] The saw block has the following functions or functional elements:

[0073] ο Guiding of saw blades used for bone cutting

[0074] ο Holes for securing saw blocks to the bone and for adjusting the cutting height up to ±4mm.

[0075] ο Adapter interface for mounting to the orientation device / handle via (saw block) adapter

[0076] ο Adapter interface for mounting the cutting height detector

[0077] The above-described inventive subject matter, which is individually protected and therefore claimed, is described in more detail below:

[0078] A first core aspect of the invention, which may be separately claimed if necessary, is particularly the provision of a directional device, especially for guiding tibial resection, having a telescopic pull-out handle (telescopic device) equipped with a sawing block at its proximal end region and a type of (foot) locking device, particularly a clamping device, at its distal end region. This clamping device comprises at least two mutually interacting and pivotable clamping elements / arms for clamping, for example, the distal end of the patient's tibia. The clamping elements of the clamping device are respectively configured in an arc shape and oriented relative to each other such that, viewed in the direction of the longitudinal axis of the directional device / handle, these clamping elements form an elliptical region therebetween, which is configured to clamply accommodate the distal end of the tibia. According to the invention, the clamping elements are respectively configured to be spring-elastic or made of a spring-elastic material, so that the clamping device of the directional device can preferably be removed from the tibia with one hand while fully utilizing the spring properties of the clamping elements.

[0079] In other words, the clamping device arranged on the distal end section of the directional device or the telescopic / pull-out handle has a preferably Y-shaped tibial abutment block, which in particular consists of two basically V-shaped, mutually separated (forming a slide) rigid abutment arms. Spring-flexible / bending clamping arms are pivotally hinged to the respective free end regions of the abutment arms, and these clamping arms are pre-formed arcuately along the closed pivot direction / around the clamping direction. If the clamping arms formed in this way pivot relative to each other in the around-clamping direction (the foot clamp is closed), the aforementioned elliptical around-clamping shape appears in the top view, thereby applying force to the tibia clamped around the ankle region almost along the entire circumference of the clamp, especially from the rear, side, and front simultaneously.

[0080] Furthermore, through the spring-elastic construction of the clamping elements, these clamping elements are secured to the distal end of the tibia in a tissue-protective manner, that is, non-invasively, with high translational and rotational stability. Here, if we refer to the lower end of the tibia, this refers to the lower third of the tibia, including the ankle joint, up to the area directly contacting the dorsum of the foot.

[0081] The directional device or foot clamp device (foot clamp) preferably includes a ratchet mechanism, through which the clamping elements are supported on the shin abutment block of the foot clamp device and through which the clamping elements can be pre-tightened independently with different amounts of pre-tightening force.

[0082] Due to the spring's elasticity, the clamping element advantageously combines high holding force with resilience and high rotational and translational stability relative to undesirable adjustments of the entire orientation device. This high stability is achieved by the clamping element being closed and additionally held by a ratchet mechanism.

[0083] Furthermore, when the foot clamp is closed, the two clamping elements cross each other at their respective free ends. This crossing allows for the simultaneous application of lateral and posterior retaining forces in an advantageous manner. Consequently, high closure and retaining forces are advantageously applied to the tibia in a multidimensional and planar manner.

[0084] This retaining force is particularly advantageous because it is constant for all circumferential dimensions of the tibia's anatomy, since the elastic clamping element is only loaded when it contacts the tibia. Thus, the clamping element achieves a dual function, as pressure for retaining the tibia is applied only when the tibia contacts the clamping element.

[0085] According to another preferred embodiment, these clamping elements are further configured as forks, and the tips of the respective forks are arranged to be offset relative to each other, such that in the closed state (closed foot clamp), these tips engage with each other in an overlapping manner, thereby firmly holding the tibia. Thus, the clamping elements simultaneously grasp and hold the tibia from the rear, side, and front. By configuring the clamping elements as forks, the clamping elements can correspondingly cross in the posterior region of the tibia and thus press against the abutment block. In a particularly advantageous manner, the clamping elements are configured such that they cross each other in the region of the ankle joint.

[0086] Preferably, the tips of the fangs are formed opposite to the corresponding arcuate shape of the clamping element, allowing the removal process from the tibia to be performed without damage. By bending the clamping element in its end region, the clamping element can be removed from the tibia with good tissue protection (without having to open the ratchet mechanism beforehand), wherein, advantageously, cutting into the tissue by the end is prevented or reduced.

[0087] The second core aspect of this invention, which may be claimed separately if necessary, is that the telescopic device, i.e., the telescopic handle, preferably has a decoupling device, i.e., a saw block adapter (also referred to as a decoupling device), in its proximal region in addition to the aforementioned foot clamp. The saw block adapter is configured to separate / decouple the saw block from the telescopic device or handle upon (manual) activation / triggering. In this way, the orientation device / orientation aid, i.e., the telescopic handle which generally has a handle, can be easily removed from the cutting block / saw block. If the foot clamp is constructed according to the aforementioned first core idea of ​​the invention in a preferred embodiment, then due to the synergistic effect therein, the clamping element, due to its inherent elasticity, can be easily (again, one-handedly) removed from the distal tibia when the spring is elastically open (and without sweeping the foot clamp on the ratchet mechanism), thereby allowing the orientation device to be removed entirely by a single movement.

[0088] In other words, the structural design of the foot clamp and proximal saw block adapter / adapter interface allows for the advantageous, tissue-protective, and non-invasive removal of the retractable handle (or directional aid) from the patient's tibia in a simple (single) maneuver.

[0089] Crucially, the retaining elements of the foot clamp are constructed with sufficient flexibility to allow the operator to easily remove them from the distal tibia without operating the release mechanism. These retaining elements also possess sufficiently high rotational and translational stability to prevent unwanted adjustment of the orientation device. Furthermore, it is advantageous in this case that the decoupling device, i.e., the adapter interface, for the tibial saw block is constructed such that the handle (preferably a lever or release button) for releasing the orientation device from the saw block can be operated with a simple thumb press, allowing the handle to be gripped by the unaffected hand. Using an orientation device with the aforementioned devices and elements, the orientation device can thus be removed from the patient's tibia with one hand after the saw block has been secured to the bone and after operating the release button by thumb, without any further action.

[0090] According to a preferred embodiment of the second core idea of ​​the invention, the telescopic device or retractable handle has a handle in its proximal region, the handle being designed such that it can be gripped by one hand and the decoupled device / saw block adapter is used to activate a pressure element above the handle, the pressure element preferably being arranged at an angle A between 90° and 150° relative to the longitudinal axis of the telescopic device, more preferably at an angle between 95° and 120°, and especially at an angle A of 100°, so that the pressure element can be activated by the thumb of said one hand.

[0091] By arranging the pressure element at a preferred angle A of 100°, a particularly easy-to-reach position for the pressure element is achieved. Thus, the pressure element can be advantageously triggered by a single thumb press, and the orientation device can be removed from the tibia by the operator's sole hand. This advantageously prevents additional hand movements or methodological steps, thereby allowing the orientation device to be removed in a single movement.

[0092] Specifically, the saw block adapter has two bolt-shaped protrusions on the side of the handle as a male adapter interface, for example, depending on the type of plug. A clamp or retaining clip is preferably rocker-shaped and supported on these protrusions. The retaining clip has at least one engaging recess (e.g., a locking hook) formed on one end section, while a pressure element is arranged on the other end section for manually pivoting the retaining clip, preferably in the release direction.

[0093] Therefore, a female adapter interface, for example, in the form of a socket with two (blind) holes, is arranged / constructed at the saw block, into which the plug can engage in a manner resistant to relative rotation. This engagement, by means of a retaining clip, is secured, for example, by a retaining edge acting from the rear on the side of the saw block. It should be explicitly noted that the male adapter interface can, of course, also be arranged on the side of the saw block, and the female adapter interface can be located on the handle.

[0094] Preferably, the saw block adapter is formed as a separate (independent) component with a mating portion at which the adapter is preferably fixedly connectable to the handle at the proximal end of the handle. More preferably, the saw block adapter has a vertical through hole, allowing a portion of the telescopic handle (sliding element, with a foot clamp disposed at the distal end of the sliding element) to slide (completely) through the handle and the adapter.

[0095] Furthermore, as a third inventive core that can be claimed separately as needed, the present invention provides a directional device for guiding tibial resection, the directional device comprising the following components:

[0096] -Preferred is a clamping device (foot clamp) for clamping the distal end of the tibia of a patient, according to the first core idea of ​​the present invention;

[0097] - Tool guide / saw block for guiding tools / saws during tibia removal.

[0098] -A telescopic device / retractable handle according to the second core idea of ​​the invention is preferred, which is connected to a tool guide / saw block and a clamping device and configured to orient these devices relative to the tibia, wherein the telescopic device has a handle element or handle configured to accommodate a slide element (together with a clamping device disposed thereon) movably supported therein, wherein the telescopic device has a (manually set) fixing element disposed between the handle and the slide element, and the fixing element can be (manually) set to a first position in which a first pressure is generated between the handle and the slide element, and the fixing element can be additionally set to a second position in which a second pressure different from (greater than) the first pressure is generated between the elements.

[0099] Therefore, a fixing element is provided, which is connected to the telescopic device and is configured to be arranged between the handle and the slide element, and is capable of generating a first pressure and a second pressure between the handle and the slide element. By providing two different pressures between the elements, the telescopic device can be easily adapted and operated according to the requirements of the therapist.

[0100] A preferred embodiment is thus provided in which the (first) pressure generated in the first part causes self-locking between the handle element and the slide element in the vertical arrangement of the orientation device, that is, in the longitudinal direction of the retractable handle, and the (second) pressure generated in the second part causes the elements to be fixed to each other.

[0101] Therefore, in the first part, a self-locking slider is advantageously implemented, wherein the self-locking is at least sufficient to prevent relative movement of the handle and slider element due to gravity, and in the second part, the slider is further secured to the handpiece by means of a fixing element. This is advantageously achieved, for example, by means of friction clamping, whereby the fixing element, i.e., the fixing screw / fastening screw, is screwed in until it stops. The self-locking release of the slider for its axial mobility in the handle is thus achieved by inserting a resilient pin into the fixing element, i.e., the fixing / fastening screw, which, in the partially open to fully open screw, generates a frictional engagement by means of a clamping force (related to the spring force) between the handle and the slider. This clamping force is designed such that the resulting static friction reacts against gravity, wherein the effective mass is significantly affected by the element fastened to the proximal and / or distal end of the orientation device. Advantageously, the clamping force allows the therapist or user to release the height setting element at any point in time and maintain the set height. The orientation device therefore does not collapse as it would be expected based on gravity. This allows the user to recalibrate the height at any time, while simultaneously focusing on other parameters such as inversion / valgus and / or inclination settings. This, in turn, advantageously simplifies the overall workflow during treatment. Only when the (rough) height adjustment is complete is the fixing / tightening screw screwed in until it stops, thereby releasing the spring action and applying a clamping force, significantly greater than the previously applied spring force, between the handle and the slide bar (element) according to the screwing force, finally securing the two elements firmly together.

[0102] In another preferred embodiment, the fixing element may be additionally configured such that a third pressure acts between the elements in the third section, the third pressure being configured such that, in the vertical arrangement of the orientation device, the elements (handle, slider) slide automatically relative to each other due to the applied gravity. Therefore, in this third section, a freely falling slider is provided.

[0103] This is achieved, for example, by the fact that the clamping pin of the fixing element no longer generates or only generates small / negligible static friction, which is caused by the fact that when the fastening screw is fully opened, the force of the spring acting on the clamping pin is so small that the described static friction is no longer relevant and only sliding friction still exists between the clamping pin and the slide bar.

[0104] A fourth core idea of ​​the present invention, which may be separately claimed if necessary, is to provide a directional device for guiding tibial resection, the directional device comprising the following components:

[0105] - Preferably, a clamping device (shackle) according to the first core idea of ​​the present invention is used to clamp the distal end of the patient's tibia;

[0106] - Tool guiding device / tibialis saw block, used to guide the tool during tibia resection.

[0107] - Preferably, a telescopic device / retractable handle according to the second and / or third core idea of ​​the invention is used, which is connected / connectable to a tool guide and a clamping device and is configured to orient these devices relative to the tibia, wherein the tool guide has a receiving recess / butt / adapter interface configured to receive a height detection element or cutting height detector (adjustable touch element) in a releasable manner to detect / fine-tune the cutting height.

[0108] According to the above implementation scheme, the cutting height detector is selectively installed on the proximal tibial saw block and is basically composed of the following components:

[0109] • The adapter interface for the tibia saw block preferably has a locking and releasing mechanism.

[0110] • A self-holding yet sliding probe arm with a probe tip, which may be necessary in some cases.

[0111] • Unit for (manual) height adjustment

[0112] The (configurable) cutting height detector has the following functions:

[0113] • Easily install and remove stents on individual tibial saw blocks with different structures when necessary (e.g., left and right legs).

[0114] A resilient locking mechanism is provided at the distal end of the stylus, which locks the stylus after it has been introduced / inserted into the hole / receiving recess / butt joint provided for this purpose in the tibial saw block. The stylus remains rotatable relative to the corresponding saw block about the insertion axis.

[0115] Selective axial locking is achieved, for example, by a "spring-loaded lug" that is laterally pushed back upon introduction due to the inclined distal abutment and engages in a groove in the tibial saw block when fully recessed into it.

[0116] The spring-loaded lug can be released from the lock by means of a lever that, during operation, pulls the lug back against the spring and thus releases the lock. In this state, the stylus can be easily removed from the saw block.

[0117] • Use the probe tip to detect bone landmarks. The landmarks selected by the user are used as references, relative to which the cutting height is set.

[0118] The marker is detected using a probe tip mounted on the rear end of the probe arm. Due to the fineness of the probe tip, very small bone structures can be detected visually and accurately using visual inspection.

[0119] • The horizontal mobility of the height sensor adapts to different anatomical structures of the tibial epiphysis and allows access to the medial and lateral tibial condyles from the same adapter site.

[0120] Various bone landmarks can be reached on the proximal surface of the tibial condyle using a preferred rotatable stylus and a preferred movable probe arm along its main axis. Here, the probe arm is sized to take into account the anatomical structures present worldwide (Asians, Caucasians, etc.).

[0121] To maintain the desired extension length of the probe arm, the probe arm can be fixed, for example, by means of friction-fitting self-locking to prevent axial movement.

[0122] • Set cutting height

[0123] By inserting the stylus into the tibia saw block and positioning it precisely on the saw block, the distance of the stylus's probe tip relative to the lower edge of the kerf in the saw block can be determined.

[0124] The set cutting height is displayed, for example, by counting around the circumference of the bolt head of the adjustable height detector. The numerical representation of the set height is preferably indicated by a display element located at the front end of the holding unit of the detector arm.

[0125] The tibial cutting thickness is set to 0 to 16 mm (or 0 to 14 mm), preferably achieved with only one turn of the bolt head. Height adjustment is made in this case by means of a helix in the guide element of the bolt head. If necessary, a stop element can be provided at the upper end of the guide element to prevent the bolt head from rotating completely downwards from the stylus.

[0126] • Finally, the cutting height is set and the orientation device is used for proximal tibial cutting:

[0127] After setting the desired cutting height, the probe is moved toward the marker selected by the user and the orientation device is oriented. Approach to the marker is achieved by moving a handle with a structural element / saw block adapter on a slide bar. If the orientation device is oriented as desired by the user in terms of height, varus / valgus, and slope, the saw block is finally anchored to the bone using a fixed spin through a fixing hole provided in the saw block. The probe must then be removed at least to allow tibial sawing to be performed.

[0128] The height detection element (also referred to herein as a cutting height detector) can be installed at the proximal tibial cut block as described above. By using the height detection element, the distance of its detection tip relative to the lower edge of the tool guide / cut block kerf is advantageously defined. Through the detection tip of the height detection element, very fine bone structures can be advantageously detected very precisely by visual inspection. Overall, the height detection element enables particularly precise orientation of the entire orientation device.

[0129] In a preferred embodiment, the receiving recess is a (pocket-shaped or through) hole extending along the longitudinal axis of the orientation device / handle from the upper side of the tool guide / saw block, wherein the height detection element has an insertion element / bolt with a locking mechanism that can be re-locked into the receiving recess.

[0130] A spring-loaded locking mechanism is provided at the distal end of the height detection element (also known as the stylus), specifically at the distal (free) end / end section of the insertion element / bolt, which locks the stylus in the receiving recess of the saw block. The stylus is advantageously kept rotatable about the insertion axis, thereby allowing the detection element to be easily oriented.

[0131] In another preferred embodiment, the locking mechanism is preferably arranged in the insertion element itself and includes a locking lug that acts behind the receiving recess in the insertion state such that the height detection element is axially held therein.

[0132] Axial locking is advantageously achieved via a spring-loaded lug that, upon insertion of the stylus, automatically pushes laterally back due to its angled distal abutment / sliding surface and engages in a side recess within the tool guide when fully recessed. The spring-loaded lug can additionally be manually pulled back laterally from the locked position by means of a lever or operating key, overcoming its spring preload, thereby disengaging the locking engagement. Advantageously, in this state, the stylus can be easily removed from the tool guide, i.e., from the saw block.

[0133] Furthermore, a fifth inventive concept that may be separately claimed by the present invention is to provide a directional device for guiding tibial resection, the directional device preferably comprising the following components:

[0134] - Preferably, a clamping device (shackle) according to the first inventive concept of the present invention is used to clamp the distal end of the patient's tibia;

[0135] - Tool guide / saw block for guiding the tool during tibia removal.

[0136] - Preferably, a telescopic device or telescopic handle according to at least one of the second to fourth core ideas of the present invention is connected / connectable to a tool guide device at its proximal end section and connected / connectable to a clamping device at its distal end section and is configured to orient the device relative to the tibia, wherein the telescopic device has an insertion device receiving portion in its proximal region for selectively accommodating a proximal fixation unit or insertion device, the insertion device receiving portion being formed by a handle, preferably a sliding handle element / sliding rod element, which is at least partially constructed as a hollow body by the telescopic device.

[0137] As described above, the orienting device according to the invention transforms from one solution variant to a second solution variant through simple instrument supplementation. These two variants involve "anterior fixation" and "proximal fixation."

[0138] The transition is addressed by placing an additional proximal fixation unit, i.e., an insertion device, on the type of "anterior fixation," thus making proximal fastening (of the "proximal fixation" type) possible at the "tibial intercondylar process."

[0139] The "proximal fixing unit" basically consists of a horizontal cantilever with an impact pin unit and a vertical support with a lever mechanism, used to clamp the unit onto the orientation device or handle, especially the sliding element. The "proximal fixing unit" is installed on the proximal end of the orientation device in a "front-fixed" type. It has the following functions:

[0140] • Simple fixation and detachment of the "proximal fixation unit" in the proximal portion of the "anterior fixation" type.

[0141] The fixed position is preferably achieved through a lever expansion mechanism.

[0142] The lever is moved upward inside the support by manipulating the lever (pressing down with the thumb).

[0143] For this purpose, the rod is guided in a hole in the distal handle (support) of the "proximal fixing unit".

[0144] A quadrilateral element inclined at, for example, 45° to the proximal end is fixedly mounted on the distal end of the rod.

[0145] The quadrilateral element mentioned above rests against the distal end of the handle of the "proximal fixing unit" at an angle of 45°, which preferably has the same quadrilateral shape as the quadrilateral element on the aforementioned rod.

[0146] Two quadrilateral elements form a unit that is pushed into a quadrilateral handle tube at the proximal end of a "front-fixed" (in the handle area) type.

[0147] The two quadrilateral elements are preferably arranged with their 45° inclined planes facing each other.

[0148] If the quadrilateral element positioned further away is now pulled toward the proximal end via a lever mechanism and a rod, then the two quadrilateral elements will be laterally misaligned due to the 45° inclined planes arranged in the opposite direction.

[0149] If this is done when both elements are in the quadrilateral tube, jamming will inevitably occur and thus result in the fixation of the "proximal fixing unit" in the proximal end (in the quadrilateral tube) of the handle of the orientation device in the "front fixing" type.

[0150] By opening the lever mechanism, the locked and disengaged "proximal fixation unit" can be removed entirely from the directional device with only one handle. Here, the lever for disengagement moves upward using the fingers (preferably the middle and / or ring fingers) when the "proximal fixation unit" is grasped.

[0151] • When there is no external force or even a small thrust, the horizontal mobility of the cantilever in the strut has self-adhesion.

[0152] The mobility of the cantilever ensures compatibility with tibial anatomy worldwide, allowing users to set the incline at any time.

[0153] • Rotation and lateral displacement are prevented by using two preferred impact pins to fix the tibial intercondylar process.

[0154] • If necessary, use an additional impact rod to loosen the pin.

[0155] • Guide the saw block or saw block adapter along the longitudinal direction of the shank during cutting height setting.

[0156] For setting the height of the saw block, the tibia saw block adapter mounted on the proximal end of the "anterior fixation" type orientation device must be released to allow axial sliding along the retractable handle and independent of the handle.

[0157] This release is achieved by manipulating the corresponding locking mechanism to disengage the coupling between the saw block adapter and the handle. The locking mechanism (slide button) is, for example, laterally mounted on the proximal end of the orientation device.

[0158] The slider occupies two functional parts:

[0159] Position 1: Locking Tibial Saw Block Adapter "Front-end fixation"

[0160] Position 2: Release the tibialis saw block adapter Proximal fixation

[0161] Therefore, the orientation device can be advantageously transformed from one solution variant to a second solution variant by simple instrument supplementation, wherein, here, this involves "anterior fixation" and "proximal fixation unit" as defined above.

[0162] A further advantage is that the driving device can be introduced into the hollow body of the handle at its distal end, that is, into at least part of the hollow and proximal open sliding element of the telescopic device, so that the driving device can be locked in the hollow body / sliding element by the clamping mechanism. Therefore, it is preferable to abandon form-fit connections, such as bolts, screws, etc., and rely solely on friction-fit connections that can be manufactured quickly and easily.

[0163] According to the sixth core idea, which can be claimed separately if necessary, the present invention preferably provides a directional device for guiding tibial resection, the directional device comprising the following components:

[0164] - Preferably, the clamping device according to the first core concept of the invention has at least two clamping elements that interact with each other for clamping the distal end of the patient's tibia, the clamping elements being secured to a suspension arm configured for insertion into a foot clamp receiving device.

[0165] - Tool guiding device for guiding the tool during tibia resection.

[0166] - A telescopic device according to at least one of the second to fifth core ideas of the invention, the telescopic device being connected to a tool guiding device and a clamping device and configured to orient the device relative to the tibia, wherein the telescopic device has a handle element configured to accommodate a slide element / slide bar element movably supported therein, wherein the orienting device includes a first slide element / slide bar element having a first length and a second slide element / slide bar element having a second length, wherein the respective slide bar element is configured to be inserted into the handle element as needed, wherein the respective slide bar is preferably connected at a right angle to the foot clamp receiving device at its distal end, and the ratio of the first length of the first slide bar element to the second length of the second slide bar element is preferably between 1 and 1.5, more preferably between 1.1 and 1.3, and especially 1.27, wherein the length from the proximal end of the slide bar to the center point of the foot clamp receiving device is measured respectively, thereby allowing different lengths of the tibia to be removed by the first and second slide bars respectively.

[0167] In other words, the sixth core idea of ​​the present invention relates to the general implementation of the following feasible solution: within the scope of a unique orientation device, the length range of the orientation device is preferably varied as cost-effectively as possible according to at least one of the first to fifth core ideas of the present invention. To this end, two measures are basically provided, which can be employed jointly or independently of each other:

[0168] Firstly, a first feasible solution exists, providing a current type of orientation device having a retractable (pull-out) handle or telescopic device, on which a sawing block is mounted or can be mounted, and on which a clamping device or foot clamp is arranged or can be mounted. The pull-out handle or telescopic device according to the invention has a sliding element / sliding bar element (or simply a sliding bar) that is axially movably received in a handle and preferably fixed relative to the handle in a selected / selectable pull-out position by means of a fixing device (fixing screw). According to the invention, the orientation device comprises a set of sliding bar / sliding handle elements (at least two sliding bars having different bar lengths from each other) with different handle / bar lengths, the sliding bar / sliding handle elements being selectively interchangeable with each other and telescopically insertable into the handle in a selected manner.

[0169] Therefore, different lengths of the tibia, i.e., different leg lengths, can be removed advantageously. This is achieved by changing the slide, which exists in different lengths within a range of available slide sets. Thus, all lengths of the tibia can be removed advantageously by means of the directional device.

[0170] Furthermore, there is a second feasible solution (which can be used alone or in combination with the aforementioned first feasible solution), namely, the clamping element of the foot clamp receiving device is longitudinally offset and fastened to the suspension arm, wherein the suspension arm can be introduced into the foot clamp receiving device by rotating 180° in a first part and a second part, such that in the first part the clamping element is oriented toward the distal end of the orientation device and in the second part toward the proximal end of the orientation device, such that when the suspension arm is rotated 180° from the first part to the second part and introduced into the foot clamp receiving device, a height misalignment of the clamping element in the longitudinal direction is caused.

[0171] In other words, current-type orienting devices are preferably provided with a retractable (pull-out) handle or telescopic device, on which a sawing block can be mounted or installed at its proximal end section, and on which a clamping device or leg iron device is arranged or can be installed. The pull-out handle / telescopic device according to the invention has a sliding element / sliding bar element (or simply sliding bar) that is axially slidably received in a handle and preferably fixed relative to the handle in a selected / selectable pull-out position by means of a fixing device (fixing screw). For this purpose, a receiving / holding portion for mounting / installing the clamping device / leg iron device is provided on the distal end section of the telescopic device, especially the sliding bar element.

[0172] The clamping / shackle device has a shackle section, preferably a Y-shaped or V-shaped tibial abutment or mounting block (as has been described with respect to the first core idea of ​​the invention), wherein the clamping element according to the first core idea of ​​the invention is supported on the tibial abutment or mounting block, wherein the shackle device also has a coupling section, preferably an insertion rod, the coupling section being able to engage with a receiving portion on the sliding rod side.

[0173] According to the invention, the leg iron section, particularly the clamping element and / or the tibial abutment block, is arranged asymmetrically with respect to the coupling section, particularly the insertion rod, that is, staggered in the longitudinal direction of the telescopic device, such that the leg iron section, particularly the clamping element, is positioned above (proximal end) or below (distal end) the coupling section (viewed in the handle direction) depending on the rotational orientation of the coupling section when the coupling section is inserted / engaged in the receiving portion on the handle side. In this way, by the corresponding rotational orientation of the coupling section during its installation, the distance between the proximal sawing block and the leg iron section, particularly the clamping element, selectively increases or decreases (depending on the asymmetry / longitudinal misalignment).

[0174] In a particularly preferred embodiment, the height misalignment of the foot clamp receiving device or insertion device from the center point of the foot clamp receiving device to the corresponding edge point of the clamping element is measured. This height misalignment is preferably between 10 mm and 20 mm, and especially 15 mm, in the first portion relative to the distal end. Additional length adjustability in both directions, preferably 15 mm, is achieved through the 180° swivelability of the foot clamp receiving device. Thus, an orientation device is generally provided by combining different lengths of the slide bar with the swivelable foot clamp receiving device or insertion device, which is highly flexible in length setting and can therefore be used for a wide range of tibial sizes. Attached Figure Description

[0175] The present invention will now be explained in more detail with reference to the accompanying drawings and preferred embodiments.

[0176] Figure 1A perspective view of the orientation device according to the invention according to a first preferred embodiment is shown.

[0177] Figure 2 It shows Figure 1 An exploded perspective view of the second preferred embodiment.

[0178] Figure 3 It shows Figure 1 and Figure 2 Side view of the orientation device in the middle.

[0179] Figure 4 A perspective view of an orientation device according to the invention, based on another preferred embodiment, is shown.

[0180] Figure 5 A perspective view of the tool guiding device is shown.

[0181] Figure 6 It shows Figure 5 A three-dimensional side view of the tool guide device in the image.

[0182] Figure 7 It shows Figure 5 A three-dimensional front view of the tool guiding device in the image.

[0183] Figure 8 A perspective view of a second embodiment of the tool guiding device is shown.

[0184] Figure 9 It shows Figure 8 A perspective side view of a second embodiment of the tool guiding device in the image.

[0185] Figure 10 It shows Figure 8 A perspective front view of a second embodiment of the tool guiding device.

[0186] Figure 11 A perspective view of the clamping device according to the invention is shown when the clamping element is closed.

[0187] Figure 12 A top view of the clamping device according to the invention is shown when the clamping element is closed.

[0188] Figure 13a A perspective view of the clamping device according to the invention is shown when the clamping element is open.

[0189] Figure 13b A further perspective view of the clamping device according to the invention is shown when the clamping element is open.

[0190] Figure 14 The ratchet mechanism of the clamping device according to the present invention is shown in FIG13.

[0191] Figure 15 The clamping device according to the invention shown in FIG13 has an inserted tibia when the clamping element is open.

[0192] Figure 16 The clamping device according to the invention shown in FIG13 has an inserted tibia when the clamping element is closed.

[0193] Figure 17 to Figure 19 The ratchet mechanism of the clamping device is shown in different settings.

[0194] Figures 20 to 23 The decoupling devices according to the invention, combined with tool guiding devices, are shown in different locations.

[0195] Figure 24 The extraction direction of the orientation device according to the invention is shown.

[0196] Figure 25 A perspective view of the decoupling device according to the present invention is shown.

[0197] Figure 26 A further perspective view of the orientation device according to the invention is shown.

[0198] Figure 27 A first perspective view of the fixing element according to the present invention is shown.

[0199] Figure 28 A further perspective view of the fixing element according to the invention is shown.

[0200] Figure 29 Figure 35 shows different detailed views of the fixing element according to the present invention.

[0201] Figure 36 A perspective view of the touch device according to the present invention is shown.

[0202] Figure 37 A further perspective view of the touch device according to the invention is shown.

[0203] Figure 38 and Figure 39 A further perspective view of the touch device according to the invention is shown.

[0204] Figures 40 to 41 Detailed diagrams of the touch device according to the present invention are shown.

[0205] Figures 42 to 44 A further perspective view of the touch device according to the invention is shown.

[0206] Figure 45 A first perspective view of the injection device according to the present invention is shown.

[0207] Figure 46 A further perspective view of the insertion device according to the present invention is shown.

[0208] Figures 47 to 51 A detailed diagram of the injection device according to the present invention is shown.

[0209] Figures 52 to 55 A perspective view of the orientation device according to the present invention is shown.

[0210] Figure 56 Different lengths of sliders are shown.

[0211] Figure 57 and Figure 58 A clamping device according to the invention is shown, and

[0212] Figures 59 to 62 A further perspective view of the orientation device according to the invention is shown.

[0213] Wherein: 1: Orientation device; 2: Clamping device; 3: Tibia; 4, 4a: Clamping element; 5: Clamping device housing; 6: Contact device; 8: Tool guide device; 10: Telescopic device; 11: Slide bar (element); 12: Saw block adapter / decoupling device; 14: Handle; 16: Pressure element; 18: Holding mechanism; 20: Longitudinal axis; 22: Elliptical area; 24: Base; 26: Male housing element; 28: Female housing element; 30: Hook element; 32: Lateral direction; 34: Longitudinal axis; 36: Adapter base; 44: Lateral concave / protruding; 50: Embossed surface; 52: Proximal area; 54: Distal area; 60: Fork; 62: Tooth; 66: Tip; 68: End of clamping element; 70: Add 74: Locking element; 76: Ratchet mechanism; 77: Preload spring; 78: Central contact area; 82: Support arm / lateral contact area; 84: Ratchet lever; 86: Slide / tibia contact block; 90: Spindle mechanism; 92: T-shaped piece; 93: Insertion rod; 94: Locking structure; 95: Horizontal carrier; 100: Receiving section; 102: Knob; 104: Fixing element; 112: Locking element; 114: Housing; 116: Bolt; 118: Groove-shaped recess; 120: Clamping pin / bolt; 122: Setting element; 124: Spring element; 128: Upper stop element; 130: Lower stop element; 150: Receiving recess; 151: Upper side; 152: Height detection assembly; 154 156: Locking mechanism; 158: Insertion element; 160: Lever element; 164: Locking lug; 165: Spring element; 166: Probe tip; 168: Helical element; 170: Cross-section of tool guide device; 172: Helical wheel; 174: Numerical value; 200: Guide pin; 201: Frame; 202: Insertion device; 203: Impact pin; 204: Insertion device housing; 208: Clamping mechanism; 210: Control element; 212: Hollow body; 214: Lever element; 216: Edge element / clamping plate; 218: Beveled section; 222: Crossbeam; 224: Insertion mechanism; 250: Sliding bar element group; 254: First sliding bar element; 258: Second sliding bar element; 262: Foot clamp housing device Center point; 268: Height misalignment; 270: Edge point; 300: Drill hole; 302: Tool guide slot; 303: Drill slot; 304: Adjusting screw / knob; 306: Fixing force; 308: Force action; 322: Hand; 334: Adapter interface; 336: Height stop; 338: Probe arm; 340: Vertical mobility; 344: Display element; 346: Horizontal mobility; 348: Rotational degree of freedom; 354: Friction mating element; 364: Locking groove; 366: Cutting height; 368: Contact level; 370: Cutting level; 372: Locking mechanism; 400: Impact rod; 402: Housing; 404: Impact pin unit; 405: Sliding brake; 406: Connecting mechanism;408: Support / Hollow Body; 410: Slide Button / Button.

[0214] The accompanying drawings are merely illustrative in nature and are intended only to understand the invention. The same elements are given the same reference numerals. Features of various embodiments may be substituted for each other. Detailed Implementation

[0215] Figure 1 The diagram illustrates a preferred extramedullary tibial orienting device according to the invention, in the "anterior fixation type," having a proximal region 52 and a distal region 54. The proximal region 52 is defined as the region facing the patient's body, and the distal region 54 is defined as the region facing away from the patient's body. The distal region 54 is therefore, for example, the region where the patient's foot / ankle is located.

[0216] Therefore, the orientation device 1 particularly includes / has:

[0217] - Telescopic device 10, which forms the middle part of the orientation device 1 and has a proximal handle 14, a distal (telescopic / pull-out) slide element 11 axially movably supported in the handle 14, and a receiving / connecting portion 5 for the distal end of the shackle / clamping device 2.

[0218] - The distal leg iron / clamping device 2, which can be inserted into or engaged with the distal receiving portion 5.

[0219] - Proximal (mounted) saw block adapter / decoupling device 12, which is preferably detachably coupled / coupled to the handle 14 on the proximal end side of the handle.

[0220] - Saw block / tool ​​guide 8, which is detachably coupled to saw block adapter 12, and preferably

[0221] - A touch device (adjustable height detector / detector) 6, which is detachably coupled to the saw block 8 on the distal side of the saw block.

[0222] A clamping device 2 is arranged in the distal region of the directional device 1. This clamping device includes / has clamping elements 4 and 4a, which are arc-shaped and thus form an elliptical region 22 between them. This elliptical region is configured to clamp or retain the tibia. The telescopic device 10 extends along the longitudinal axis 20. A handle 14 is arranged in the proximal region of the telescopic device 10. The saw block adapter / decoupling device 12 is (directly or indirectly) connected / arranged on the handle at its distal end / end section and thus selectively forms a unit with the handle 14. An actuating / pressure element 16 is provided on the saw block adapter 12, which is preferably arranged / oriented at an angle A relative to the handle 14. Therefore, the actuating / pressure element points towards the proximal region 52 (upward), so that the therapist can surround the handle 14 with the fingers of one hand and simultaneously operate the pressure element 16 with his thumb. A sawing block (also known as a tool guide) 8 is arranged in the proximal region 52, and a contact device 6 is releasably fastened to the sawing block. A pressure element 16 acts on a decoupling device (sawing block adapter) 12, which is configured to separate the telescopic device 10 from the tool guide (sawing block) 8. Once the tool guide 8 is fixedly connected to the tibia, it can thus be decoupled from the telescopic device 10 via the pressure element 16 by triggering the decoupling device 12.

[0223] Figure 2 An exploded view shows the orientation device 1 of the "proximal fixation type".

[0224] Orientation device 1 and Figure 1 A telescopic device 10 is provided in its middle portion, which is connected / possibly connected to the tool guide / saw block 8 in its proximal region 52 via a saw block adapter 12, and a contact device 6 is fastened / possibly fastened to the tool guide / saw block. Furthermore, a driving device 202 is additionally fastened / possibly fastened to the telescopic device 10 (adaptively / selectively). In the distal region 54, a clamping device 2 is fastened / possibly fastened to the telescopic device 10, which has clamping elements 4, 4a. In this respect, according to... Figure 2 The orientation device 1 is conceptually corresponding to the one based on Figure 1 The orientation device differs in that the insertion device 202 is additionally mounted on the telescopic device 10 at the proximal end section.

[0225] Figure 3 The side view and also the exploded view are shown according to Figure 2 The orientation device 1, and Figure 4 The orientation device 1 is shown in its fully installed state. Especially according to... Figure 3In the view, the various interfaces on the orientation device 1 according to the invention are at least partially visible. Thus, the sawing block 8 can engage with the sawing block adapter / decoupling device 12, the detection device 6 engages with the sawing block 8, and the driving device 202 engages with the telescopic device 10 and, in particular, selectively engages with the distal slide element 11 at its proximal / end section, for which the distal slide element axially (completely) penetrates the handle 14 in the proximal direction. Figure 4 The diagram shows how the inserting device 202 is inserted into the proximal end section of the slide element 11.

[0226] Figures 5 to 10 Different views of the tool guide / saw block 8 and the saw block adapter / decoupling device 12 are shown. Figure 5 The diagram shows a tool guide 8 together with a decoupling device 12, the decoupling device including a pressure element / button 16. The tool guide / saw block 8 preferably has a lateral entry hole 300, which can be used to secure the saw block 8 to the tibia by screws or nails. The tool guide / saw block 8 is configured to guidely receive a tool / saw for cutting the tibia, for which a tool guide / saw kerf 302 is constructed in the saw block 8. Figure 6 The tool guide device 8 is shown, having a tool guide slit 302 in a state separated from the saw block adapter 12, the tool guide slit being oriented horizontally in a state fixed to the tibia. Figure 7 The tool guide device 8 is shown, having a female coupling section that currently has two height-spaced receiving holes 28 and an additional drive slot 303 configured to receive fastening elements or nails for driving into the tibia.

[0227] The tool guiding device, i.e., the saw block 8, has the following functions or the following functional components:

[0228] -Guide the saw blade for the bone segment within the guide seam 302.

[0229] - Provides drive / fastening holes 300 and / or drive slots 303 for securing the tool guide device 8, i.e., the saw block, to the bone and, if necessary, for adjusting the cutting height up to + / -4 mm.

[0230] - Provides an adapter interface (with a female coupling section having a receiving hole 28) for mounting on the directional / telescopic device 10, and

[0231] - Provides an adapter interface for mounting the detection device / cutting height detector 6.

[0232] also, Figure 5 and Figure 8 For example, different types of sawing blocks 8 according to the present invention are shown, namely, the type of "front fixed variant" ( Figure 5 ) and the type of "proximal fixation variant" ( Figure 8 ), wherein the adapter interface (insertion hole) for cutting the height detector 6 is relative to the... Figure 5 The types are staggered, or two adapter interfaces are set up for the two variant schemes.

[0233] Figures 11 to 13b A perspective view of clamping device 2 is shown. Figure 13a The clamping device 2 is shown, having two clamping elements / clamping arms 4 and 4a. The clamping elements 4 and 4a are tibially curved and extend gently (outwardly curved) at their respective free ends, allowing the clamping elements 4, 4a to be removed from the tibia or ankle (spring-loaded) without damage, and without the free clamping arm ends scraping the patient's skin.

[0234] Specifically, the clamping device 2 has a mounting block in the form of a T-shaped piece 92, an insertion rod 93 preferably quadrilateral (rectangular) in cross-section, and a hollow cross-body 95. A spindle mechanism / spindle 90 is supported in the cross-body, and the spindle mechanism / spindle can be rotated about its longitudinal axis by means of a knob 304 arranged at the end of the cross-body 95. A slide (tibia rest block) 86 is supported on the cross-body 95, into which the spindle 90 engages, so that the slide 86 can reciprocate along the cross-body 95 by means of a rotating head 304 when the spindle 90 is manually rotated. Furthermore, the slide 86 has a central / middle abutment area 78 and two V-shaped abutment arms 82 oriented relative to each other, with ratchet mechanisms 76 arranged / mounted on their free end sections, on which clamping elements 4, 4a are respectively engaged, such that the clamping elements 4, 4a are pivotally supported on the abutment arms 82 and can be manually pivoted toward each other (in the closing direction), wherein the corresponding ratchet mechanism 76 first prevents pivoting back (in the opening direction).

[0235] In addition, each ratchet mechanism 76 has a preload spring 77 (this preload spring is particularly important in...) Figure 11 (Shown as a helical torsion spring), the preload spring preloads the corresponding clamping elements 4, 4a in the opening direction. Finally, each ratchet mechanism 76 has a ratchet lever 84, by which the corresponding ratchet mechanism 76 is unlockable / releasable.

[0236] Clamping elements 4 and 4a are made of pre-bent (plate) spring steel and consist of a plurality of side-by-side serrations or fingers 62 spaced apart from each other in a forked manner 60, such that the serrations / finger 62 of the clamping elements 4 and 4a can engage each other in an overlapping manner when they pivot in the closing direction and thus ensure reliable fixation to the tibia 3.

[0237] Figure 11 A clamping device 2 is shown with closed clamping elements 4 and 4a, which engage with each other so that the tibia 3 can be fully clamped or held on the clamping elements. To pre-tighten the clamping elements 4 and 4a, a ratchet lever 84 is first pressed with a movement away from each other, thereby engaging the pawls (pawls in...) Figure 11 The diagram schematically shows a pawl / tooth, integrally constructed with the ratchet lever 84, engaging with the external teeth on the corresponding clamping elements 4, 4a. When it is necessary to release the clamping elements 4, 4a, the ratchet lever 84 is slightly pressed inward (towards each other) (see [reference]). Figure 11 This disengages the pawl from its corresponding clamping elements 4, 4a, thus eliminating the ratchet action. The clamping elements 4, 4a can move in both directions along the transverse carrier 95 on a common slide 86 via the spindle mechanism 90, which is inherently mounted on the rotating head 304. As described above, the spindle mechanism 90 is integrated into the transverse carrier 95. In this way, the clamping elements 4, 4a, while already surrounding the tibia, can be optimally oriented in the transverse direction of the tibia, without the risk of injury to the patient or physician due to protrusions such as those from the spindle.

[0238] The T-shaped member 92, together with the slide 86 and the abutment arm 82 arranged thereon, forms a basic Y-shaped tibial abutment block mounting unit, which can be inserted into the corresponding distal shackle receiving part 5 on the side of the telescopic device 10.

[0239] For this purpose, the T-shaped member 92 forms a mandrel / insertion bar 93, which preferably has a rectangular cross-section and has a locking / gripping structure 94 on at least two longitudinal sides that are opposite to each other, by which the entire clamping device 2 or mounting unit is movably fastened / can be fastened to the telescopic device 10 or its receiving portion 5.

[0240] Figure 12 The clamping device 2 is shown in a top view and in the closed state, wherein an elliptical region 22 for receiving the tibia is constructed between the clamping elements 4, 4a (schematically shown). Figure 12 (As shown in the diagram). Here, the tibia 3 is accommodated by a V-shaped abutment block / element 86 (including lateral abutment arms 82 and clamping elements 4, 4a). An angle C is formed in the intermediate abutment area 78 between the V-shaped abutment block 86 and the lateral abutment arms 82, which is preferably 45° on each side (that is, the two abutment arms 82 form a common angle of approximately 90°). Thus, a particularly ergonomic abutment of the tibia is constructed in the V-shaped abutment block 86.

[0241] also, Figure 12 The direction of force applied to the tibia 3 is shown, which can be achieved by the foot cuff 2 according to the invention.

[0242] Therefore, the two clamping elements 4, 4a, with their pointed teeth / finger-like prongs, cross / hook / overlap on the dorsal side of the tibia, thereby pressing the tibia against the anterior abutment block / slide 86, completely surround the tibia. Because the clamping elements 4, 4a are pre-bent and spring-loaded, they can also apply clamping force to the tibia from the sides, thus almost clamping the tibia. This... Figure 12 The force arrow is clearly shown in the middle.

[0243] Figure 13a A clamping device 2 is shown with clamping elements 4, 4a in the open position, allowing the tibia to be inserted. The clamping elements 4, 4a or the ratchet mechanism is released by the relative oriented movement of the ratchet levers 84, so that the clamping elements 4, 4a can be placed in the open position due to internal spring preload. The ratchet mechanism is then restarted by the distancing movement of the two ratchet levers 84, allowing the clamping elements 4, 4a to be individually brought into the closed position and locked there.

[0244] As previously implemented, the one or more knobs 304 are configured to induce lateral adjustability of the slide / tibia rest block 86 and the clamping elements 4, 4a supported thereon, wherein the spindle 90 for offsetting the slide 86, operable by means of the knobs 304, is integrated into the T-shaped member 92 or the crossbeam 95.

[0245] Figure 13b A clamping device 2 is shown with corresponding clamping elements 4 and 4a, which are configured such that the clamping elements engage with each other via corresponding forks 60, thereby clamping the tibia almost around its circumference and, if necessary, generating an almost constant clamping force in the circumferential direction.

[0246] Figure 14 The clamping device 2, clamping element 4, and hinge area 86 of the abutment block / slide 86 are shown. The clamping element 4 is coupled to a ratchet mechanism 76, which can be released via a ratchet lever 84, wherein... Figure 14 Only one ratchet lever 84 is shown. The pawl (not labeled) of the ratchet lever 84 is visible, spring-loaded and engaged in the outer teeth of the hinge area of ​​the clamping element 4, and the ratchet lever 84 integrally connected to the pawl for pushing the pawl out of the outer teeth. A knob 304 is also shown, allowing the tibial abutment block 86 to be adjusted / moved in the lateral direction.

[0247] Figure 15A top view of the clamping device 2 in the open state is shown. Here, clamping elements 4, 4a are coupled to the ratchet mechanism 76 via their respective (inner / near the hinge) ends / hinge regions 68. Clamping elements 4, 4a are preferably made of thin sheet metal or other elastic material. At the free ends / tips 66 of the clamping elements, clamping elements 4, 4a are respectively (radially) pointed outward (bent outward) so that the respective clamping elements 4, 4a can be removed or pulled out from the tibia without damage. The ends 68 of the clamping elements 4, 4a near the hinge are preferably reinforced with plastic parts (reinforcing elements) 70 (or covered with plastic) so as to achieve a gentle introduction of torque into the additional structure, making the clamping elements 4, 4a sufficiently durable.

[0248] Figure 16 The clamping elements 4, 4a are also shown in their closed state. An elliptical region 22 for accommodating the tibia or ankle joint is constructed between the clamping elements 4, 4a. A force application 308 is constructed via the clamping elements 4, 4a, the V-shaped abutment element / abutment block / slide 86, and the corresponding lateral abutment areas / abutment arms 82 of the abutment block 86, the force application acting circumferentially around the tibia. Specifically, the clamping elements 4, 4a are designed such that the force application 308 acts on the tibia at multiple different locations in the circumferential direction, thereby securing the tibia in place around its perimeter.

[0249] from Figure 13b Combining Chinese and foreign elements, for example Figure 3 It can be seen that the spatial arrangement of the clamping arms 4 and 4a of the abutment block 86 or T-shaped piece 92 is as follows.

[0250] Therefore, the clamping / clamping arms 4, 4a (in the manner of a shovel) are arranged at a height offset from the T-shaped member 92, i.e., they are not on the same plane as the T-shaped member 92. This directly results in, according to Figure 3 When the T-shaped part 92 is rotated to the 92 position, the clamping arms 4 and 4a are below the T-shaped part 92, while when the T-shaped part 92 is rotated 180°, the clamping arms 4 and 4a are above the T-shaped part 92.

[0251] It should be noted that the insertion mandrel 93 is based on... Figure 13a The material is a quadrilateral profile, and the receiving portion 5 thus forms a rectangular receiving cylinder at the distal end of the telescopic device 10. The insert mandrel 93 is introduced into the receiving cylinder and locked in the receiving cylinder. As a result, depending on the rotational orientation of the T-shaped member 92, the distance between the clamping arms 4, 4a (above or below the T-shaped member 92) and the sawing block 8 arranged near the proximal end increases or decreases, thereby additionally reducing or increasing the overall length range of the telescopic device 10.

[0252] Figure 17a b to Figure 19The clamping device 2 is shown in cross-section. Figure 17a Figures 4 and 4a show clamping elements 4 and 4a, respectively, which are coupled to the ratchet mechanism 76 via their hinge-proximity ends 68. Figure 17a The open clamping section is shown and Figure 17b The clamping elements 4, 4a are shown in the closed clamping position. A spring 77 can be seen preloading the clamping elements 4, 4a in the opening direction, and two ratchet mechanisms 76 together with ratchet levers 84 connected thereto for manually and individually stopping the ratchet action.

[0253] Figure 18 and Figure 19 The clamping device 2, with corresponding clamping elements 4, 4a, is shown in an enlarged view. These clamping elements are coupled to corresponding ratchet mechanisms 76. Additionally, the relaxed return springs 77 of the respective ratchet mechanisms 76 can be seen.

[0254] The clamping device 2 (also known as the foot clamp) is designed so that the telescopic device 10 can be removed from the patient's tibia in a tissue-protective (i.e., non-invasive) manner, both at the proximal adapter interface 12 of the tibial saw block 8 and in a particularly simple operation, utilizing the spring elasticity of the clamping arms 4, 4a. That is, if the surgeon attempts to remove the telescopic device 10 from the tibia while leaving the saw block 8 on the tibia, he only needs to manipulate the button 16 to decouple the saw block 8 from the telescopic device 10 and simply pull out the clamping device 2 (without manipulating the ratchet lever 84).

[0255] Furthermore, the spring elasticity of the clamping arms 4, 4a generates a clamping force that remains almost constant around the tibial ring, thus avoiding hemmatomes caused by point forces. The clamping device 2, i.e., the foot clamp, is particularly useful for this task in that…

[0256] - These clamping elements 4, 4a, i.e., the retaining elements of the shackles 2, are sufficiently resilient so that they can be easily removed from the distal tibia without operating the release mechanism, and the distal tibia simultaneously possesses sufficiently high rotational and translational stability to prevent undesirable adjustment by the ETA, and

[0257] - The ratchet mechanism 76 can also be opened manually using the ratchet lever 84.

[0258] The ratchet mechanism 76 is activated / deactivated via a corresponding ratchet lever 84. Alternatively, instead of simply removing the clamping elements 4, 4a from the tibia, the ratchet lever 84 can be released. The two clamping elements 4, 4a automatically open and thus release the tibia via the return spring 77 after the ratchet lever 84 is actuated.

[0259] As previously implemented, the adapter interface for the tibial saw block 8, i.e., the tool guide device, is designed such that the saw block adapter 12 constituting the adapter interface can be easily manipulated by thumb pressing onto the button 16 to release the telescopic device 10 from the saw block 8, thereby releasing the saw block 8 by the retaining mechanism 18 (described in more detail below). With the above-described modification of the saw block 8 and clamping device 2, the telescopic device 10, including the adapter 12 and clamping device 2, can now be removed from the patient's tibia by (solely) hand and thumb pressing, and by fully utilizing the spring elasticity of the clamping arms 4, 4a, after the saw block 8 is secured to the tibia and the saw block adapter 12 is operated (i.e., the retaining mechanism 18 is operated), without further manipulation. This greatly facilitates the operation of the entire orientation device 1.

[0260] Figures 20 to 23 Various perspective views of the tool guide device / saw block 8 combined with the decoupling device / saw block adapter 12 are shown. Figure 20 In this configuration, the tool guide 8 is (selectively) fastened / coupled to the decoupling device 12. Here, the decoupling device 12 has a retaining mechanism 18 including a pressure element 16, which preferably has an embossed surface 50. Here, the thumb pressure of the corresponding therapist is applied to the embossed surface 50 of the pressure element 16.

[0261] Figure 21 The interaction between the tool guide device 8 and the decoupling device 12 is illustrated. Specifically, the tool guide device 8 has an adapter base 36, which in turn has a plurality of female receiving elements 28. The female receiving elements 28 are preferably recesses / holes in the adapter base 36, which are configured to form-fit the corresponding male receiving elements / protrusions / pins 26 of the decoupling device 12. By engaging the respective male receiving elements 26 into the respective female receiving elements 28, the tool guide device 8 is reliably held on the decoupling device 12 in all three spatial directions. A retaining mechanism 18 in the form of a fixing clamp or hook element 30 is additionally supported on the decoupling device 12, which is configured to surround the adapter base 36 of the tool guide device 8 or hook onto a corresponding side recess 44 in the adapter base.

[0262] Figure 22A side view of the tool guide 8 and the saw block adapter 12 in their coupled state is shown. Therefore, the retaining clamp 30 is preferably constructed of a sheet metal member that is chamfered in the case of forming a hollow profile in a basic U-shape, wherein the side flanges of the two separately terminating webs / U-shaped profiles are formed as hooks and the connecting webs of the U-shaped profile are formed as pressure elements 16. This retaining clamp 30, thus designed, is hinged to the base 24 of the saw block adapter 12 on both sides (that is, the base 24 is housed within the U-shaped hollow profile). The U-shaped hollow profile thus forms a rocker arm of a certain type together with the pressure element 16 on one side of the rocker arm hinge and the hook on the other side. According to... Figure 22 In the coupled state, the hook of the retaining clamp 30 engages with the side recess 44 in the form of a bolt-shaped or pin-shaped protrusion on the saw block 8, especially on its mounting / adapter base 36, and thus fixes the saw block to the adapter interface of the saw block adapter 12.

[0263] In addition, Figure 22 The image shows a lateral operating button on the base 24 of the saw block adapter 12, which cooperates with a locking mechanism (symbolically shown on the lower end side of the saw block adapter 12). By means of this locking mechanism, the saw block adapter 12 can be coupled to the handle 14 on the upper end side (upper handle section) so as to selectively form a unit with the handle 14, for example in… Figure 15 As shown in the image.

[0264] Figure 23 The operation of the decoupling device / saw block adapter 12 (especially the retaining mechanism) and the tool guide device / saw block 8 is shown, which should be coupled to the base 24 of the decoupling device 12.

[0265] As can be seen, by pressing the pressure element 16 with the thumb, the retaining clamp 30 pivots and its hook can be lifted. In this state, the sawing block 8 can be placed on the adapter interface of the decoupling device 12, wherein, according to the plug and socket principle, the male protrusion / bolt 26 is inserted into the female recess / hole 28. Finally, the pressure element 16 is released, thereby causing the hook of the retaining clamp 30 to pivot downward (due to gravity or spring preload) and act on the protrusion 44 on the sawing block 8 (see...). Figure 22 The decoupling device 12 is separated from the saw block 8 in the opposite manner.

[0266] Figure 24This illustrates the removal / removal direction of the directional device 1 (telescopic device 10 along with the foot clamp 2 and adapter 12) when the tool guide device 8 is fastened / held to the tibia and thus should be separated from the telescopic device 10. The therapist here uses the force of their thumb to press on the embossed surface 50 of the pressure element 16 (thus holding the clamp 30 to release the sawing block 8) and simply pulls the telescopic device 10 along with the clamping device 2 from the patient's tibia. Here, the clamping device 2 is not opened separately, but rather the clamping elements 4, 4a open (automatically) upon pull-out due to their spring elasticity. The therapist's shown hand 322 here surrounds the telescopic device 10 or handle 14.

[0267] Figure 25 The therapist's hand 322 is shown, which generates thumb pressure on the pressure element 16 of the telescopic device 10. The fingers of the therapist's hand 322 clamp the telescopic device 10 onto the handle 14.

[0268] Figure 26 and Figure 27 The present invention illustrates an orientation device 1 having a telescopic device 10 according to a "proximal fixation variant," wherein a clamping device 2, preferably according to the above description, is provided in the distal region of the telescopic device 10, and a tool guide device 8, preferably according to the above description, is arranged above the adapter 12 in the proximal region, on which a fastening / fastenable contact device 6 is preferably mounted. Figure 26 and Figure 27 The transverse direction 32 shown here indicates the direction of approach of the patient's tibia.

[0269] A fixing or securing element 104 is provided on the telescopic device 10 (in all fixed variations), which is preferably insertable into the telescopic device 10 from the front of the directional device 1 when viewed in the lateral direction 32. Furthermore, the securing element 104 is configured to self-lock the telescopic device 10 in selected longitudinal positions at different locations and / or allow it to be freely pulled apart from each other. Additionally, the securing element 104 is configured to be inserted in the lateral direction 32 into a receiving element / receiving section 100 constructed on the handle 14. Furthermore, a locking element 112 is arranged on the receiving section 100, configured to be manually moved to a release position in which the securing element 104 can be removed from the receiving section 100, while in the (unoperated) locking position, the locking element 112 retains the securing element 104 in the receiving section 100.

[0270] Figure 28The slider element 11 is shown in an enlarged illustration, wherein a longitudinal groove-shaped recess (hereinafter referred to as the longitudinal groove) 118 is constructed on the side facing the fixing element 104, the recess being defined at the distal and proximal ends by end stops, the recess defining the minimum and maximum pull-out positions (telescopic stroke) when the fixing element 104 is slidably engaged with the longitudinal groove 118.

[0271] Figures 29 to 35 Different detailed views of the fixing element 104 are shown.

[0272] Figure 29 A fixing element 104 is shown in a side view. This fixing element is configured to be inserted into a corresponding receiving section 100 on the telescopic device 10 and held therein by means of a locking element 112. The corresponding receiving section 100 is located at the distal end region of the handle element 14. Here, the handle element 14 surrounds the slide element 11. Furthermore, in Figure 29 The bolt 116, protruding radially (downward) from the fixing element 104, can also be clearly seen; this bolt serves as an engaging element / side recess for the locking element 112. Of course, other locking solutions, such as bayonet locks or threaded connections, are also conceivable.

[0273] Figure 30 A partial cross-section is shown of the receiving section 100, including the locking element 112, and the fixing element 104. Thus, the fixing element 104 typically consists of a spring-loaded internal bolt 120 and a preferably sleeve-shaped housing 114, the internal bolt being axially movably supported in a knob 102 to engage in a longitudinal groove 118 of the slide element 11, the housing being rotatably accommodating the knob 102 to apply a fixing force to the slide element 11, either around or parallel to the spring preload.

[0274] Figure 31 and Figure 32 The locking element 104 is shown in detail, which is inserted into the receiving section 100 of the handle 14. Thus, a slider (not shown) is received in the longitudinal groove 118 of the slide bar 11, in which a bolt 120 is axially supported. The bolt 120 has / forms a spring seat in its intermediate section, on which a helical spring 124 is supported to apply a preload force toward the slider to the bolt 120. The spring seat also serves as a stop element, abutting against a shoulder in the knob 102, thereby preventing the bolt 120 and spring 124 from falling off the knob 102. The bolt 120 and the preload spring 124 are received in the knob 102 in its axial direction, the knob being axially inserted / screwed into a preferably sleeve-shaped housing 114, which is in turn inserted into the receiving section 100 and held / secured therein by means of the locking element 112 (see especially...). Figure 31 The adjusting screw 122 is screwed into the knob 102 on its end side (on its free end side), and this adjusting screw serves as a support for the preload spring 124. If the adjusting screw 122 is thus rotated within the knob 102, the spring preload on the bolt 120 (within the knob) can be changed in this way.

[0275] In addition, the bolt 120 has a coil section 121 that extends from the spring seat in the direction toward the adjusting screw 122 and is surrounded by and thereby guides the preload spring 124.

[0276] Figure 33 The fixing element 104 and its setting element / adjusting screw 122 are shown, such as its setting screw, which is configured to set the preload acting on the bolt (clamping pin) 120. Additionally, a locking element 112 is visible, which locks the fixing element 104 into the receiving section 100 of the handle 14. Figure 33 The lower region shows the slider element 11, which shows the upper stop section 128 of the groove-shaped recess 118, which represents one of the two maximum pull-out positions 128, 130 of the slider element 11 relative to the handle 14.

[0277] The following uses the appendix Figures 31 to 35 Briefly explain the working principle of the fixed element 104:

[0278] First, the fixing element 104 is preferably slidably inserted into the receiving section 100 (into a hole constructed therein) and the sleeve-shaped housing 114 of the fixing element is fixed in a way that resists relative rotation and is axially fixed by means of the locking element 112. In this state, the bolt / clamping pin 120 within the knob 104 extends into the longitudinal groove 118 of the slide element 11 and (indirectly through the slider housed in the longitudinal groove 118) is loaded by pressure according to the preload of the spring 124. In this way, the preload of the spring 124 can be increased and / or decreased by rotating the adjusting screw 122 within the knob 104, thereby changing the friction between the slide 11 and the bolt 120 of the fixing element 104. Thus, for example, friction can be reduced to approximately zero or increased such that the current travel portion of the telescopic device 10 is prevented from being adjusted due to gravity.

[0279] To determine the (freeze) stroke position, knob 104 can be further screwed into sleeve-shaped housing 114, thereby pressing knob 104 directly, i.e., specifically via coil section 121 of bolt 120 (which is now axially supported on adjusting screw 122 in knob 102) onto the slider and pressing / tensioning the slider directly onto slide bar 11 without spring preload.

[0280] The following uses Figures 36 to 44 Describe the height-touching device (also known as a height-fixed / height-adjusting unit) 6.

[0281] Figure 36 The tool guide / saw block 8, preferably according to the previously described embodiment, includes / has a receiving recess / hole 150 into which the height sensing element / height adjustment unit 6 can be selectively inserted. Here, the tool guide 8 has only one or more receiving holes / recesses 150, wherein, it should be noted, it may instead be provided with a lateral notch with a clamping clamp, a magnet retainer, or the like. The at least one receiving recess 150 is formed as part of an adapter interface 334 between the tool guide / saw block 8 and the height adjustment unit 6.

[0282] In principle, the height adjustment unit 6 basically includes

[0283] - Detector tip 166, the detector tip is mounted or constructed on detector arm 338 (together forming height detection assembly 152),

[0284] - Spindle mechanism 168, on which a probe arm 338 for at least one height adjustment is supported, and

[0285] - Insert the spindle / handle 156, preferably with a locking device / locking mechanism 154 as an additional part of the adapter interface 334, for engaging with the receiving recess 150 from the upper side 151 of the sawing block 8.

[0286] Figure 37A perspective view of the height adjustment unit 6 according to the invention is shown. The height adjustment unit 6 thus has a horizontal degree of freedom of movement 346, a vertical degree of freedom of alignment 340, and a rotational degree of freedom 348. The height adjustment unit 6 has an insertion mandrel / handle 156, preferably constructed as a hollow handle, in which a locking device 154 is accommodated. This locking device engages laterally with a receiving recess 150 on the side of the saw block 8 to axially fix the height adjustment unit 6 onto the saw block 8. For this purpose, a spring-preloaded locking lug 160 is provided in the insertion mandrel 156, which protrudes laterally / radially on the circumference of the handle 156 and can be pulled back into the insertion mandrel 156 by an operating key 158 to release the locking engagement with the saw block 8. The rotational degree of freedom 348 is thus caused by the rotational freedom of the insertion mandrel / handle 156 within the receiving hole 150 of the tibial saw block 8.

[0287] The probe arm 338 is provided with an elongated hole (see...) Figure 37 The elongated hole (slidingly / freely) is passed through the spindle mechanism / spindle 168, and the probe arm 338 is coupled to the spindle mechanism / spindle via an intermediately connected friction-fitting element / retaining carriage 354, which frictionally but longitudinally movable (pull-out) holds the probe arm 338 on the spindle mechanism 168. Therefore, the horizontal degree of freedom 346 is caused by the horizontal mobility of the height probe assembly 152 or the probe arm 338 on the spindle mechanism 168 (via the friction-fitting element 354).

[0288] Figure 38 A height detection element 6 is shown in a side view, configured for insertion into a tool guide device 8. The height detection element 6 thus has an insertion mandrel 156 and an actuating element in the form of a lever 158 on its underside (facing the saw block 8). This lever, in its unoperated state, rests against a lever stop (not shown), which is arranged or constructed on the insertion mandrel 156. Furthermore, a detection tip 166 is provided on the outer (proximal) end of a detection arm 338 for contacting the tibial bone landmark. Finally, a spindle mechanism with a spindle / helix 168 is shown, axially coupled to the insertion mandrel 156 and carrying a friction-fitting element 354, including the detection arm 338, in its intermediate section.

[0289] Figure 39 and Figure 40The saw block / tool ​​guide 8 is shown in perspective, with the height adjustment unit 6 inserted into it. The spindle mechanism of the height adjustment unit 6 has a spindle / helical element 168 as described above and a helical wheel 172 mounted / supported on the helical element 168. The helical wheel 172 is rotatably coupled to a friction engagement element 354, such that the friction engagement element (including the probe arm 338) is held on the spindle 168 by the helical wheel 172 (allowing for axial movement).

[0290] Figure 40 The truncated part is in Figure 41 As shown in the image. Figure 41 A locking device 154 with a locking lug 160 is shown, which is inserted into a receiving recess 150 on the sawing block 8. Furthermore, a spring element 164 can be seen, which is arranged between the lever stop and the operating lever 158 for operating the locking lug 160 and preloading the lever 158 into a position in which the locking lug 160 is in the locking engagement position (according to...). Figure 41 (Radially protruding). Specifically, lever 158 is configured as a two-legged reversing lever bent at a right angle, which is pivotally supported in its middle section within insert spindle 156, wherein one leg forms the operating lever / operating section and the other leg is effectively connected to locking lug 160, which is preferably constructed in the form of a slider and is radially outwardly pressed by one leg of the operating lever 158 via its spring preload.

[0291] Figure 42 and Figure 43 A tool guide / saw block 8 with an insertion height adjustment unit 6 in different set positions is shown.

[0292] According to Figure 42 The setting location and according to Figure 43 The set cutting height / cutting height difference (or touch level) 366 can be seen between the set positions. Here, touch level 368 defines the height of the probe tip 166 relative to the horizontal saw kerf in the saw block 8, which defines the cutting level 370.

[0293] Figure 44A tool guide 8 is also shown, having a height detection element 152 placed thereon, the height detection element having a helical element / spindle 168. The helical element 168 can be manipulated by a helical wheel 172 for height setting of the height detection assembly 152. Specifically, the helical / spindle 168 is preferably rotatably guided in an insert spindle 156, wherein the height detection assembly 152 is screwed onto the helical 168 via a friction-fitting element 354. The helical wheel 172 (as another component of the height detection assembly 152) is rotatably supported on the friction-fitting element 354, such that rotation of the helical wheel 172 on the helical / spindle 168 causes movement of the detection arm 338 along the spindle 168. Finally, a locking mechanism 372 is preferably arranged between the friction-fitting element 354 and the helical wheel 172, the locking mechanism being configured to maintain the defined height (axial position on the spindle) of the height detection element 152.

[0294] The operation of the height adjustment unit / cutting height detector 6 according to the present invention can be summarized as follows:

[0295] The settable cutting height detector 6 has a basic function: it is mounted on the tool guide 8, i.e., on the tibia saw block, as a simple mounting and dismounting unit. A spring-loaded locking mechanism, hereinafter referred to as reference numeral 154, is provided at the distal end of the stylus, i.e., at the distal end of the height fixing unit 6. After the stylus is introduced / inserted into the receiving recess (through hole) 150 provided for it in the tibia saw block 8, the locking mechanism 154 locks the stylus, wherein, preferably, the stylus remains rotatable about the insertion axis.

[0296] Here, axial locking is achieved by a spring-loaded locking lug 160. This means that when the insert mandrel 156 is introduced / inserted into the receiving recess 150, the spring-loaded locking lug 160 is laterally pushed back into the insert mandrel 156 due to its externally inclined (distal) abutment / sliding surface, and when fully introduced into the tibial saw block 8, the locking lug 160 is preferably engaged in a groove in the tibial saw block 8. The spring-loaded locking lug 160 is released from the engaged position by means of an operating lever 158, which pulls the locking lug 160 back against the spring 164 when the operating lever 158 is manually pivoted. In this state, the stylus 8 can be easily removed from the saw block. Furthermore, the detection of bone landmarks of the tibia is achieved using the probe tip 166. The landmarks selected by the user are used as references, and the cutting height of the tool guide 8 is set by rotating the auger wheel 172 accordingly. The marker is detected using a probe tip 166 mounted on the end of the probe arm 338. Due to the detection precision of the probe tip 166, even very small bone structures can be detected visually and accurately by means of visual inspection.

[0297] The horizontal mobility of the height detection component 152, particularly the detection arm 338, is used to adapt to different anatomical structures of the tibia and to achieve orientation from the medial and lateral sides of the tibia at the same adapter site. For this purpose, the horizontal mobility of the detection arm 338 is provided on the friction-fitting element 354, which allows for... Figure 37 As shown in the diagram, any bone landmark can be reached on the proximal surface of the tibia by means of a rotating stylus and a probe arm 338 that can move along its main axis. Here, the probe arm 338 is sized to accommodate anatomical structures that exist worldwide (e.g., Asians or Caucasians).

[0298] To maintain the desired extension length of the probe arm 338, the probe arm 338 is prevented from moving axially on the friction-fitting element 354 by means of a friction-locking mechanism. The probe tip 166 is reliably positioned relative to the saw wrench in the saw block 8 by engaging the probe in the tool guide device 8, i.e., in the tibial saw block, and by the defined stop of the probe on the saw block 8. The distance of the lower edge, wherein the set cutting height is indicated, for example, by a number 344 on the circumference of the auger wheel 172. The number indicating the set height is preferably indicated by a display element on the front end of the friction-fitting element 354 (holding unit).

[0299] For example, the tibial cut thickness can be set to 0 to 16 mm (or 0 to 14 mm) with only one revolution of the spiral wheel 172. A stop element / stop section at the upper end of the spiral 168 prevents the spiral wheel 172 from rotating completely downward from the stylus.

[0300] After setting the desired cutting height relative to the probe tip 166, the height detection assembly 152 is driven onto the marker selected by the user and the orientation device is oriented. Approach to the marker is achieved, in particular, by moving the handle 14 with the structural element along the slide bar 11 (manually) with the clamping device 2 already engaged at the distal end. If the orientation device 1 is oriented in height, inversion, eversion, and slope as desired by the user, the tool guide device 8, i.e., the saw block, is finally anchored to the bone using a retaining pin, preferably a nail, through a retaining hole 300 provided for this purpose. The stylus must then be / can be removed in order to perform the tibia sawing. For this purpose, the telescopic device 1 can remain on the tibia or be simply removed along with the clamping device 2 and the adapter 12, while the saw block 8 (without the removed stylus 6) remains on the tibia.

[0301] The proximal fixation unit / fixation device 202 is described below, which is preferably selectively installed on the proximal end section of the telescopic device 10 according to the above description, so as to convert the orientation device of the front fixation type into the orientation device of the proximal fixation type.

[0302] to this end, Figure 45 An optional proximal insertion device / fixation unit 202 is shown, which preferably has at least the following components:

[0303] - Insertion mechanism 224, which is configured to insert two pins preferably slidably guided within the insertion mechanism 224.

[0304] - Impact rod 400, the impact rod is set and constructed to release two driven pins, and

[0305] - Connecting mechanism 406 for connecting the proximal fixing unit 202 (preferably clamping) to the orienting device (telescopic device) of the "front fixing" type for selectively / temporarily generating the orienting device in the "proximal fixing" type.

[0306] In detail, the fixing device 202 includes a crossbody 222, an insertion mechanism 224, and an impact rod 400 arranged on the free end section of the crossbody. The insertion mechanism 224 has an impact pin unit 404, which serves as an anvil for preferably two impact pins. For this purpose, a central guide pin 200 is fixedly anchored in the crossbody 222 at an angle of approximately 90° to the longitudinal axis of the crossbody, and an anvil in the form of a frame / frame housing 201 surrounding the guide pin 200 is slidably supported on the crossbody. On the underside of the anvil / frame 201 facing the crossbody 222, preferably two impact pins 203 are fixed in a parallel orientation to the guide pin 200, and the impact pins are preferably supported / guided in two through holes in the crossbody 222. If a hammer is thus applied manually on the anvil, the hammer will drive the pin 203, which is held / fixed on the anvil and longitudinally guided in the transverse carrier 222, into the patient's bone, wherein the direction of insertion is ensured by the guide pin 200, which is fixed on the transverse carrier 222 and longitudinally guides the anvil.

[0307] The impact rod 400 is rocker-hinged to the cross-body 222 and has an engagement section on the side facing the insertion mechanism 224 and an impact section on the opposite side. The engagement section is operatively engaged with the anvil / frame housing 201 and can be impacted using a hammer or similar impact tool. That is, impacting the impact section of the rocker-hinged impact rod 400, with its engagement section opposite to the pin insertion direction, applies force to the underside of the frame housing 201, thereby pulling the pin 203 out of the patient's bone.

[0308] The transverse carrier 222 is axially slidably inserted into the receiving housing / fixed element 402, in which a sliding / sliding brake, for example in the form of a bent leaf spring, is disposed. Figure 45 (As shown in the diagram) 405, the slip / slide brake brakes the axial sliding of the transverse carrier 222 within the housing 402. Here, the transverse carrier 222 is preferably made of a polygonal profile (rectangular profile) to prevent the transverse carrier 222 from rotating about its longitudinal axis within the housing 402.

[0309] A support / post 408 is fixed to the housing 402. The support / post is oriented substantially at a right angle or slightly inclined to the cross support 222, and a connecting mechanism 406, preferably in the form of a locking / clamping mechanism 208, is provided in / on the support / post (see especially...). Figure 47 The clamping mechanism 208 is used to selectively fasten the fixing unit 202 to the telescopic device 10. The clamping mechanism 208 is based on... Figure 47The support is essentially composed of a wedge-shaped clamping plate 216, which abuts against the free distal end side of the support column 408, wherein the end side of the support column 408 is preferably wedge-shaped inclined / bent about the longitudinal axis of the column. The support column 408 is formed by a body 210 that is at least partially tubular (hollow), in which a pulling element (pulling bar) or a control element 210 is supported in a longitudinally movable manner. The clamping plate 216 is effectively connected to an operating lever 214 via the pulling element (pulling bar) or control element 210 guided in the support column 408, the operating lever being pivotally supported on a receiving housing 402 for the cross support 222. The operating lever 214 is based on... Figure 48 and Figure 49 It has an operating section with preferably rough or ribbed buttons for applying anti-slip pressure to the operating lever 214, for example, by means of the user's thumb. If the operating lever 214 is thus flipped and thus a pulling force is applied to the pull bar 210, the wedge-shaped clamping plate 216 moves radially outward along the (wedge-shaped) inclined end side 218 of the column 408 and thereby artificially enlarges the total cross-section of the column 408.

[0310] Furthermore, the strut 408 has a region with a small cross-sectional area in its (distal) end section facing away from the shell and a region with a large cross-sectional area in its (proximal) end section facing the shell, they are connected by surrounding shoulders (see especially) Figure 48 They are separated from each other. The region with a small cross-section is sized such that this region (with a small gap) can be inserted into the hollow telescopic rod / slide element 11 of the telescopic device 10 and fixed therein by means of the clamping mechanism 208. The region with a large cross-section substantially corresponds to the outer cross-section of the slide element 11, such that a substantially smooth slide surface is produced when the support 408 is fully inserted into the slide element 11 (up to the surrounding shoulder that serves as a stop).

[0311] Figure 46 The fixing unit 202 and the driving mechanism 224 are shown, including their manipulation possibilities. Therefore, fixing by driving in the pin 203 is preferably achieved by hammering. The pin 203 is released by further hammering acting on the impact rod 400. The clamping mechanism 208 is activated / deactivated by operating the button 214.

[0312] Figure 47The fixing unit 202 is shown, which has a fixing mechanism 224 and a connecting / clamping mechanism 208. When the connecting / clamping mechanism 208 or its manual operating lever 214 is in the upward (proximal direction) pulling position, the clamping effect between the support 408 and the slide element 11 is eliminated, and in the proximal fixing variant of the orientation device 1, the support 408 is inserted into the slide element. Here, the connecting / clamping mechanism 208 acts on the wedge-shaped clamping plate 216 via the operating element / traction bar 210, the clamping plate being able to move radially outward or inward about the support 408 via the oblique cut 218 on the distal end side of the support 408. Once the clamping plate 216 is pulled upward (in the proximal direction) via the pull bar 210 by pressing down (in the distal direction) on the actuating lever 214, the clamping plate 216 moves laterally, especially radially outward, together with the slide bar 11 into the clamping position, and the support 408 has been introduced into the slide bar. Conversely, when the lever 214 is pressed upward, the actuating element 210, i.e., the bar, moves downward (in the distal direction) and releases the clamping plate 216. The clamping plate moves radially inward due to its wedge shape, thereby canceling the clamping action.

[0313] Figure 47 The diagram is enlarged to show the data based on... Figure 48 The closed clamping mechanism 208, wherein, as described above, the actuating lever 216 moves downward. Therefore, the wedge-shaped clamping plate 216 is also inclined at an angle of approximately 45° relative to the plate's central axis on its side facing the post 408. Approximately the same inclined surface is also located on the free (distal) end side of the post 408, thus maintaining the clamping plate 216 approximately perpendicular to the central axis of the post 408 during effective engagement / sliding engagement of the two inclined sides. However, as an alternative to this structure, according to... Figures 48 to 51 Alternatively, an expansion cone of a type may be provided at the distal end / end section of the hollow support 408, which, upon corresponding actuation of the lever 214, pulls the distal end section into the hollow / tubular support 408 and radially elastically expands the support. For this purpose, an expansion slot (not shown further) may be formed in the distal end section of the support 408. It is also conceivable to provide an elastic tensioner (e.g., made of plastic material) at the distal end of the support 408, which is axially compressed together upon actuation of the lever 214, thereby causing the plastic material to be radially extruded outwards.

[0314] Figures 52 to 55 The diagram illustrates the orientation device in the "front-fixed variant," particularly the telescopic device 10 with a tool guide 8 adapted to it. A longitudinal axis 20, serving as a reference axis, extends along the longitudinal direction of the telescopic device 10, the longitudinal axis being aligned with... Figure 52This is also the central axis of the slide bar 11. The saw block adapter 12 can be clearly seen, which is axially (along the longitudinal axis 20) guided above / proximal to the handle 14 via the adapter on the slide bar 11, wherein the slide bar 11 protrudes from a through-hole formed therein on the upper (proximal) side of the saw block adapter 12, such as, for example... Figure 54 As shown.

[0315] Figure 53 The telescopic device 10 is shown in an exploded view, according to which the slide bar 11 is constructed as a hollow handle with an open end side in the proximal direction. In the exploded view shown, a tool guide / saw block 8 and an optional fixation unit 202 for selectively constructing the orientation device 1 are shown as a "proximal fixation variant." The external dimensions of the slide bar 11 and the support 408 of the fixation unit 202 are clearly shown so that the support / support 408 can be introduced into the slide bar 11 with almost no gap in its distal end section having a smaller outer diameter, up to a shoulder for length setting / adaptation of the slide bar 11 to the patient's anatomy, which separates the distal end section of the support itself with a smaller outer diameter from the proximal section with a larger outer diameter, which substantially corresponds to the outer diameter of the slide bar 11.

[0316] Figure 54 The tool guide device 8 and adapter 12 are shown. The adapter is positioned above the handle 14 onto the slide bar 11, and the adapter's operating element, preferably a button / slide 410, is not operated / pressed, so that the tibial cutting block adapter 12 is locked onto the handle 14 of the telescopic device 10 to form a unit. In this state, the handle 14 can move relative to the slide bar 11 to orient the stylus 166. This corresponds to the orienting device 1 in the anterior fixed variant. Figure 55 The telescopic device 10 is shown, wherein the button 410 on the adapter 12 is pressed, thereby disengaging the tibial cutting block adapter 12 from the handle 14 and thus allowing it to move freely relative to the handle. The insertion device 202 is inserted into the hollow body / slide element 11. This corresponds to the orientation device 1 in the proximal fixation variant, according to which the telescopic device 10, i.e., the slide 11, extends in the proximal direction via the support 408 and thus forms a motion guide for the extension of the saw block adapter 12.

[0317] Figure 56The diagram shows a slider element group 250, which consists, for example, of at least two slider elements 254 and 258 with different lengths from each other. The first slider element 254 has, for example, a first (short) length, which is, for example, 207 mm, thus characterizing a short slider. The second slider 258 has a second (long) length, which differs from the first length and is, for example, 264 mm. Here, the longitudinal axis of the foot clamp receiving device / receiving cylinder 5 defines the respective lower points of the sliders 254 and 258, from which the lengths of the sliders can be measured individually.

[0318] It should be noted that the assembly 250 of the slides according to the invention may also have more than two slides of different lengths. It is also entirely conceivable that, as an alternative or supplement to this, multiple fixing units with struts 408 of different lengths may be provided in one assembly to take into account different patient anatomy.

[0319] Figure 57 The distal end region of the telescopic device 10 with a foot clamp receiving device / receiving cylinder 5 is shown, wherein the foot clamp receiving device / receiving cylinder is fastened to the first (short) slide bar 254. Here, the suspension arm 93 is received by the foot clamp receiving device 5. By rotating and orienting the suspension arm 93 accordingly in the receiving cylinder 5, the clamping elements 4, 4a are arranged offset relative to the suspension arm 93 toward the distal end. Therefore, this results in a length change of +15 mm compared to the central clamping element arrangement implemented as described above.

[0320] Figure 58 The second portion of the foot clamping device is shown. In this configuration, the clamping elements 4, 4a are arranged offset (i.e., upward) relative to the suspension arm 93 toward the proximal end, wherein the suspension arm 93 is in turn received by the foot clamp receiving device 5. The central axis of the foot clamp receiving device 2 and the upper edges of the foot clamping elements 4, 4a show a height misalignment of 268. In this second portion, an average length variation of -15 mm is provided compared to the central clamping element arrangement.

[0321] Figure 59 An orientation device 1 with a tool guide 8 is shown, the tool guide being mounted on a short slide bar 254. Figure 60 An orientation device 1 with a long slider 258 is shown, which protrudes significantly further towards the proximal end above the handle 14 than the short slider type.

[0322] Figure 61 An orientation device 1 with a tool guide 8 and a touch device 6 is shown for a “front-fixed” type, wherein a saw block adapter 12 for fine-tuning the height distance between the probe 166 and the saw block 8 is detached from the handle 14. Figure 62The orientation device 1 is shown, which includes a tool guide device 8 and a contact device 6 having an insertion device 202 for proximal fixation additionally disposed on the orientation device. In this case, the saw block adapter 12 is also detached from the handle 14. By constructing a set of slides of different lengths according to the invention, the orientation device 1 can be used for different leg lengths given worldwide, for example for Asians with short leg lengths or Caucasians with very long leg lengths. This is advantageously achieved by simply replacing slides with different lengths.

[0323] With this length implementation scheme, the following leg lengths can be set:

[0324] - The leg length can be set from approximately 200mm to approximately 380mm using the short slider 254, and

[0325] - The leg length can be set from approximately 260mm to approximately 438mm using the long slider 258.

[0326] By overlapping the effective lengths of the two sliders 254 and 258 by approximately 120 mm, the user can select one of the sliders 254 and 258 and use it to advantageously apply the orientation device 1 to most patients.

[0327] Regarding the two implementation methods used for orientation, the length setting is preferably different as follows:

[0328] -For example in Figure 61 The “front fixation” shown has a first slider 254 having a length 256 from about 200 mm to about 360 mm and a second slider element 258 having a length from about 260 mm to about 420 mm.

[0329] -for Figure 62 The orientation device 1 of the embodiment shown, which features "proximal fixation," has a first slider 254 of short slider length having a first length from 255 mm to approximately 380 mm. Regarding the second length of the second slider element 258, for... Figure 62 In the embodiment shown with proximal fixation, the second slider element has a length from about 315 mm to about 438 mm.

[0330] Furthermore, the 180° swivel capability of the foot clamp 2 allows for length variations of + or -15mm, as described above. Figure 57 and Figure 58 As shown. This length change is advantageously achieved without replacing the slide bar 11. The + or -15 mm length change achieved by the steerability of the foot clamp has already been included in the above description of the length change of the orientation device. For the very short length of the tibia, there is also a setting that can be reduced to approximately 180 mm in the "anterior fixation". Figure 61 The possibilities shown in the diagram. However, this has the consequence that the elongated hole or insertion suture 302 in the tool guide device 8 (i.e., tibial saw block) cannot be used for the type of primary anterior fixation of the orientation device (ETA).

[0331] The preferred embodiments of the orientation device 1 according to the present invention are described in summary below:

[0332] A first embodiment of the directional device 1 for tibial resection guidance has:

[0333] - Clamping device 2, having at least two clamping elements 4, 4a that interact with each other for clamping the distal end of the patient's tibia 3;

[0334] - A tool guide device or saw block 8 used to guide the tool during the removal of the tibia 3.

[0335] - Optionally, a contacting device 6 for contacting the proximal end of the tibia 3 may be mounted on the tool guide device 8, and

[0336] - Telescopic device 10, which is detachably connected to tool guide device 8 at its proximal end and detachably connected to clamping device 2 at its distal end, and the telescopic device is configured to orient devices 2 and 6 relative to the tibia 3.

[0337] in,

[0338] - The telescopic device 10 additionally has a decoupling device or cutting block adapter 12 in its proximal region 52, the cutting block adapter being configured to separate the saw block 8 from the telescopic device 10 upon manual activation; and / or

[0339] - The clamping element 4 of the clamping device 2 is flexible, so that the telescopic device 10 can preferably be removed from the tibia by utilizing the flexibility of the clamping element after the decoupling device 12 is activated.

[0340] Furthermore, it can be specified that the telescopic device 10 has a handle 14 in its proximal region 52, which is designed to be gripped by one hand of the operator, and the decoupling device / saw block adapter 12 has an actuating / pressure element 16 above the handle 14 for activation / saw block release. This actuating / pressure element is preferably arranged at an angle A18 between 90° and 150° relative to the longitudinal axis 20 of the telescopic device 10, more preferably at an angle A between 95° and 120°, and especially at an angle A18 of 100°, so that the pressure element 16 can be operated by the thumb of the hand 56.

[0341] Furthermore, it can be specified that the clamping device 2 is arranged in the distal region 54 of the telescopic device, and that the two spring-elastic clamping elements 4, 4a each have an arc shape, such that the clamping elements are oriented relative to each other such that when viewed in the direction of the longitudinal axis 20 of the telescopic device 10, these clamping elements form an elliptical region 22 between them in the closed state, the elliptical region being configured to clamply accommodate the distal region of the tibia 3.

[0342] Furthermore, it can be specified that the decoupling device 12 has a base 24, which includes at least one male (or female) receiving element 26, the male (or female) receiving element being configured to engage in a form-fitting action with at least one female (or male) receiving element 28 of the tool guide device 8, and the actuating / pressure element 16 of the decoupling device 12 has a hook / clamp element 30 for effective connection, the hook / clamp element being configured to include a lateral recess on the tool guide device 8, preferably including at least one pin / pin element 44 extending from the tool guide device 8 in the lateral direction 32 to the longitudinal axis 34, thereby preventing the receiving elements 26, 28 from becoming detached from each other in the closed state. The male receiving element 28 is preferably designed to be tapered.

[0343] Furthermore, it can be specified that the base 24 of the decoupling device 12 has a bearing bolt, which is preferably arranged between the at least one male receiving element 26 and the receiving recess 40 of the slide bar 11 for the telescopic device 10 when viewed in the lateral direction, and the hook / clamp element 30 is preferably pivotally arranged / supported on the bearing bolt at an angle of up to 30°.

[0344] Furthermore, it can be specified that the pin element 44 of the tool guide device 8 is constructed in a teardrop shape when viewed in the lateral direction, and the hook element 30 slides along the teardrop shape 44 and is thereby lifted when the male receiving element 26 of the tool guide device 8 is engaged in the female receiving element 28 of the base 24, so that the hook element 30 and the teardrop-shaped pin element 44 lock together when the receiving elements 26, 28 are engaged with each other.

[0345] Furthermore, it can be specified that the base 24 of the decoupling device additionally has a stop bolt extending in its lateral direction 32, the stop bolt preferably being arranged between the bearing bolt and the stop surface for the tool guide device 8, and additionally forming a stop notch in the hook element 30, the stop notch being configured to form a pivot end stop of the hook element 30 by cooperating with the stop bolt when the tool guide device 8 is not locked.

[0346] An independently claimable embodiment of the orientation device 1 for tibial resection guidance is provided in which the orientation device has a clamping device 2 in its distal region 54, the clamping device comprising at least two clamping elements 4, 4a that act against each other for clamping the distal end of the patient's tibia; wherein the clamping elements 4 of the clamping device 2 are respectively configured to be arcuate and oriented relative to each other such that the clamping elements (in the closed state) form an elliptical region 22 between the clamping elements when viewed along the longitudinal axis 20 of the orientation device 1, the elliptical region being configured to clamply accommodate the distal region of the tibia, wherein the clamping elements 4, 4a are respectively configured to be spring-elastic, thereby enabling the clamping device 2 of the orientation device (1) to be removed from the tibia (5) with one hand.

[0347] Furthermore, it can be specified that the clamping elements 4, 4a are additionally forked, and the tines 62 of the corresponding forks 60 are arranged to be staggered relative to each other, such that the tines overlap and engage with each other in the closed state, so that the tibia 3 is firmly held.

[0348] Furthermore, it can be specified that the corresponding tip 66 of the fang 62 is shaped opposite to the corresponding arc shape of the clamping elements 4, 4a, so that the removal process from the tibia 3 can be performed without trauma.

[0349] Furthermore, it can be specified that the (far end / near the hinge) ends 68 of the clamping elements / clamping forks 4, 4a are respectively included / enclosed and held by reinforcing elements 70, which connect the respective clamping elements 4, 4a to locking elements 74 connected to the V-shaped abutment block 86, wherein the reinforcing elements 70 are preferably made of plastic.

[0350] Furthermore, it can be specified that the locking element 74 has a ratchet mechanism 76, which allows the clamping element / clamping fork 4, 4a to be pre-tightened, so that a set pre-tightening force is applied to the tibia in the closed state 64.

[0351] Furthermore, it can be specified that the V-shaped abutment block 86, viewed along the longitudinal direction 20 of the orientation device 1, has a central abutment area 78, from which lateral abutment arms 82 extend in a V-shape on both sides, having an angle C preferably in the range of 30° and 60°, more preferably in the range of 40° and 50°, and especially an angle of 45°.

[0352] Furthermore, it can be specified that the V-shaped abutment block 86 is laterally adjustable to the T-shaped member 92 via the main shaft mechanism 90 (thereby forming a Y-shape together with the support arm 82 of the abutment block 86), and the T-shaped member is preferably adjustablely connected to the telescopic device 10 of the orientation device 1 via the locking structure 94.

[0353] The embodiment of the directional device 1 for tibial resection guidance, which may be independently claimed, has the following features:

[0354] - A (distal) clamping device 2 for clamping the distal end of the patient's tibia;

[0355] -A (proximal) tool guiding device 8 for guiding tools during tibial resection.

[0356] - A telescopic device 10, which is connected / possibly connectable to a tool guide device 8 at its proximal end and to a clamping device 2 at its distal end, and is configured to orient the proximal and distal devices 2, 6 relative to the tibia, wherein the telescopic device 10 has a handle element 14 configured to retractably accommodate a slide bar element 11 slidably supported therein, wherein...

[0357] The telescopic device 10 has a fixing / fixing element 104 arranged between a handle element 14 and a slide element 11, and the fixing / fixing element can be set in a first position, in which a first pressure is generated between the elements 14 and 11, the first pressure allowing braking relative movement of the two elements 14 and 11, and the fixing / fixing element can additionally be set in a second position, in which a second pressure is generated between the elements 14 and 11, the two elements 14 and 11 being fixed to each other.

[0358] Furthermore, it can be specified that the fixing element 104 may be additionally configured such that a third pressure acts between elements 14 and 11 in the third location, the third pressure allowing the two elements 14 and 11 to move relatively without being braked.

[0359] Furthermore, it may be specified that a locking element 112 is arranged between the fixing element 104 and the telescopic device 10, the locking element being configured to hold the fixing element 104 on the telescopic device 10 in a locking position and to cause the fixing element 104 to be released in a release position, thereby allowing the fixing element to be removed from the telescopic device 10.

[0360] Furthermore, it can be specified that the slide element 11 has a groove-shaped recess 118 in its longitudinal extension, the recess being configured to receive and guide the clamping pin 120 of the fixing element 104. The groove-shaped recess 118 advantageously provides defined guidance for the clamping pin 120.

[0361] Furthermore, it can be specified that the fixing element 104 has a setting element 122, which acts on the spring element 124 of the fixing element 104 in such a way that the pressure / clamping force generated by the spring element 124 can be set in the corresponding positions 106, 108, 110.

[0362] Furthermore, it can be specified that, when viewed along the lateral direction 32 of the orienting device 1, a receiving element / receiving section 100 is arranged / constructed on the handle 14 on the side opposite to the tibia, the receiving element / receiving section being constructed to preferably movably receive the locking element 112.

[0363] Furthermore, it may be specified that the slider element 11 has stops 128, 130 at its two axial end sections in its recessed recess 118 for fixing the element 104, so as to prevent the slider element 11 from sliding out of the handle element 14.

[0364] Embodiments of the directional device 1 for tibial resection guidance that can be independently claimed if necessary include:

[0365] - Clamping device 2, used to clamp the distal end of the patient's tibia 3;

[0366] - Tool guiding device 8, used to guide the tool during tibial resection.

[0367] - Telescopic device 10, which is connected to tool guide device 8 at its proximal end and clamping device 2 at its distal end, and the telescopic device is configured to orient devices 2 and 8 relative to the tibia 3.

[0368] in,

[0369] The tool guide device 8 has a receiving recess 150, which is configured to receive a touch device 6 for detecting the cutting height in a releasable manner.

[0370] Furthermore, it can be specified that the receiving recess 150 is a hole extending from the proximal upper side 151 of the tool guide device 8 along the longitudinal axis 20 of the orientation device 1, and the contact device 6 has an insertion element / insertion spindle 156 including a locking mechanism 154, which is axially lockable (and rotatably) insertable into the receiving recess 150.

[0371] Furthermore, it can be specified that the locking mechanism 154 has a lever element / operating lever 158, which is preferably arranged in / on the insertion mandrel 156 and can operate the locking lug 160 by means of the lever element / operating lever. The locking lug engages behind the receiving recess 150 in the inserted state of the insertion mandrel 156 so that the contact device 6 is axially held in the receiving recess.

[0372] Furthermore, it can be specified that the touch device 6 has a height detection component 152, which has a detection tip 166 arranged on the proximal end of the detection arm 338, which is configurably fixed to the tool guide device 8 along the longitudinal direction 34 and the transverse direction 32 of the orientation device 1.

[0373] Furthermore, it may be specified that a helical element 168 is provided between the insertion mandrel 156 and the probe tip 166 for setting along the longitudinal direction 20. The helical element preferably slides / freely passes through the probe arm 338 and is configured to readablely output the height distance of the probe tip 166 relative to the cross-sectional plane 170 of the tool guide device 8.

[0374] Furthermore, it can be specified that the helical element 168 has a helical wheel 172 that is rotatably held thereon and is in threaded engagement with the helical element 168, the helical wheel preferably having a value 174 on its circumference through which the height distance can be set.

[0375] The embodiment of the directional device 1 for tibial resection guidance, which may be independently claimed if necessary, has the following features:

[0376] - Distal clamping device 2 for clamping the distal end of the patient's tibia 3;

[0377] -A (proximal) tool guiding device 8 for guiding tools during tibial resection.

[0378] - A telescopic device 10, having a handle 14 and a slide bar 11 slidably guided in the handle 14, wherein the telescopic device 10 is connected to a tool guide device 8 at its proximal end and to a clamping device 2 at its distal end and is configured to orient the devices 2 and 8 relative to the tibia 3 (longitudinally), wherein,

[0379] The telescopic device 10 has an insertion device receiving portion 204 in its proximal end region 52 for accommodating the insertion device 202, the insertion device receiving portion being formed by a slide bar 11 of the telescopic device 10, which is at least segmentally constructed as a hollow body. Preferably, the slide bar 11 completely passes through the handle 14 in the longitudinal direction of the telescopic device 10 (in the structural position) and thus forms the insertion device receiving portion 204 at the proximal end of the handle 14.

[0380] Furthermore, it can be specified that the inserting device 202 can be introduced into the hollow section of the slide bar 11 at its distal end, so that the clamping mechanism 208 can lock the inserting device 202 in the hollow section.

[0381] Furthermore, it can be specified that the clamping mechanism 208 has an elongated control element 210, preferably in the form of a pull bar / pressure bar, which is movably guided inside the hollow body / support tube 408 of the insertion device 202 and is movable in the longitudinal direction 20 in its proximal region by means of a lever element 214, such that the (manual) operating force of loading the lever element 214 can be applied to the clamping / edge element 216 that can be clamped to the hollow body section of the slide bar 11.

[0382] Furthermore, it can be specified that the hollow body 408 of the driving device 202 has a chamfered portion 218 at its distal end / end side, and the edge element 216 also has a corresponding chamfered portion 220 at its end / end side facing the control element 210, so that the edge element 216 slides on the hollow body 408 of the driving device 202 in the lateral / radial direction 32 when the control element 210 applies tension, thereby allowing the edge element 216 of the driving device 202 to be clamped with the slide bar 11 of the telescopic device 10.

[0383] Furthermore, it can be stipulated that the insertion device 202 and the slide bar 11 of the telescopic device 10 terminate flush with each other on the circumferential side in the inserted state, so that the tool guide device 8 is movable along the slide bar 11 of the telescopic device 10 and the hollow body 408 of the insertion device 202 in the longitudinal direction 20.

[0384] Furthermore, it can be specified that the insertion device 202 has a crossbeam 222 on its proximal end section, which is substantially perpendicular to the hollow body 408 and longitudinally movably supported on the hollow body 408, and the crossbeam has a fixing device 224 on its free (proximal) end section for fixing the orientation device 1 proximally to the tibia 3. Advantageously, the insertion device 202 is supported freely in all three spatial directions (that is, along the height of the hollow body 408, along the transverse direction of the crossbeam 222, and, if necessary, rotatably about the hollow body 408) by this embodiment and is therefore adaptable to corresponding boundary conditions.

[0385] Preferred embodiments of the directional device 1 that can be independently claimed for protection when necessary include:

[0386] - (Distal) clamping device 2, having at least two clamping elements / clamping arms 4, 4a pivotally relative to each other for clamping the distal end of the patient's tibia 3, said clamping elements / clamping arms being supported on a suspension arm 93, said suspension arm being configured to be introduced into a (distal) foot clamp receiving device 5 on the telescopic device 10 of the orientation device 1.

[0387] - Tool guiding device 8, used to guide the tool during tibial resection.

[0388] - A telescopic device 10, connected to a tool guide device 8 and a clamping device 2, and configured to orient devices 2 and 6 relative to the tibia 3, wherein the telescopic device 10 has a handle element 14 that longitudinally supports a slide element 11 within itself, wherein...

[0389] The orientation device 1 includes a set of 250 slider elements, comprising at least one first slider element 254 having a first short slider length and at least one second slider element 258 having a second long slider length. Each slider element 254, 258 of the slider set 250 according to the invention is configured to be inserted into the handle element 14 as needed. Each slider 254, 258 of the slider set 250 is otherwise constructed to be identical to each other and, particularly at its distal end section, is connected to / constructed with the foot clamp receiving device 5. The ratio of the first length of the first slider element 254 to the second length of the second slider element 258 is preferably between 1 and 1.5, more preferably between 1.1 and 1.3, and especially 1.27, such that different lengths of the tibia can be removed by the first slider 254 and the second slider 258 of the slider set 250. The length from the proximal end of the slider 254, 258 to the central axis 262 of the foot clamp receiving device 5 is measured.

[0390] According to an embodiment of the orientation device 1 of the present invention, which may be independently claimed if necessary, the clamping elements / clamping arms 4, 4a of the foot clamp receiving device 5 are axially offset about the longitudinal direction of the suspension arm 93, wherein the suspension arm 93 can be introduced into the foot clamp receiving device 5 in a first part and a second part by rotating 180° respectively, such that in the first part, the clamping elements 4, 4a are positioned relative to the distal end of the orientation device 1 and in the second part relative to the proximal end of the orientation device 1, thereby causing the clamping elements 4, 4a to be displaced in height / longitudinal direction 20 along the longitudinal direction 20 of the telescopic device 10 when the suspension arm 93 is rotated 180° from the first part to the second part and introduced into the foot clamp receiving device 5.

[0391] Furthermore, it can be specified that the height misalignment of the foot clamp receiving device 5 is measured from the central axis 262 of the foot clamp receiving device 5 to the corresponding hinge point 270 of the clamping elements 4, 4a, and preferably between 10 mm and 20 mm, and especially 15 mm.

Claims

1. A directional device (1) for guiding tibial resection, comprising a telescopic device (10) which may be equipped with or fitted with a sawing block (8) at a proximal end region of the telescopic device and a footcuff device (2) at a distal end region of the telescopic device, the footcuff device having at least two mutually interacting and pivotable clamping elements (4, 4a) for clamping the distal end of the patient's tibia, wherein, The clamping elements (4, 4a) of the clamping device (2) are respectively constructed in an arc shape, wherein The clamping elements (4, 4a) are at least segmentally spring-elastic, such that the clamping device (2) can be removed from the tibia only when the spring elasticity of the clamping elements (4, 4a) is fully utilized, wherein the clamping elements (4, 4a) are made of pre-bent spring steel, and Its features are, The clamping device (2) further includes a ratchet mechanism (76) for each clamping arm (4a, 4b), wherein each ratchet mechanism (76) has a preload spring (77) that preloads the clamping element (4, 4a) to which it belongs in the opening direction.

2. The orientation device (1) according to claim 1, characterized in that, The clamping device (2) includes a tibial abutment block (86) comprising two rigid abutment arms (82) that are generally V-shaped and separated from each other, and spring-bending / flexible clamping elements (4, 4a) that are pivotally hinged to the respective free end regions of the abutment arms.

3. The orientation device (1) according to claim 2, characterized in that, The clamping device (2) further includes a ratchet mechanism (76), wherein the clamping elements (4, 4a) are supported on the tibial abutment block (86) by the ratchet mechanism and the clamping elements (4, 4a) are independently pre-tightened by the ratchet mechanism with different pre-tightening forces.

4. The orientation device (1) according to claim 1, characterized in that, The clamping elements (4, 4a) are additionally configured in a fork shape and the fangs (62) of the corresponding forks (60) are arranged staggered from each other, such that the fangs overlap and engage with each other in the closed state (64).

5. The orientation device (1) according to claim 1, characterized in that, The clamping elements (4, 4a) have an elliptical region (22) between them, which is configured to clamp or hold the tibia.

6. The orientation device (1) according to claim 1, characterized in that, Each ratchet mechanism (76) has a ratchet lever (84) through which the ratchet mechanism (76) to which the ratchet lever belongs can be released.

Images