DEVICE FOR REPOSITIONING BONE FRACTURE FRAGMENTS

Abstract

A device for repositioning bone fracture fragments is disclosed. The device has a carrier assembly and a first arm assembly attached to the carrier assembly, the first arm assembly configured to hold a first bone fracture fragment. The device also has a second arm assembly attached to the carrier assembly, the second arm assembly configured to hold a second bone fracture fragment. The device further has an actuator assembly configured to adjust the second arm assembly, and an operating assembly configured to control an adjustment of the second arm assembly via the actuator assembly. The operating assembly is a manually operatable operating assembly.

Claims

1. A device for repositioning hone fracture fragments, comprising: a carrier assembly; a first arm assembly attached to the carrier assembly, the first arm assembly configured to hold a first bone fracture fragment; a second arm assembly attached to the carrier assembly, the second arm assembly configured to hold a second bone fracture fragment; an actuator assembly configured to adjust the second arm assembly; and an operating assembly configured to control an adjustment of the second arm assembly via the actuator assembly; wherein the operating assembly is a manually operatable operating assembly.

2. The device according to claim 1, wherein: on an end portion of the first arm assembly facing away from the carrier assembly a first holder assembly configured to hold a Schanz screw is provided; and on an end portion of the second arm assembly facing away from the carrier assembly a second holder assembly configured to hold a Schanz screw is provided.

3. The device according to claim 1, wherein via the actuator assembly, the second arm assembly is adjustable so that a position of the second holder assembly relative to the carrier assembly is adjustable in a plurality of directions.

4. The device according to claim 3, wherein the second arm assembly is adjustable via the actuator assembly so that the position and an alignment of the second holder assembly is adjustable about six degrees of freedom.

5. The device according to claim 1, wherein an end portion of the first arm assembly facing the carrier assembly is firmly fastened to the carrier assembly.

6. The device according to claim 2, wherein the first arm assembly has at least one manually adjustable articulated joint.

7. The device according to claim 6, wherein a securing assembly configured to secure the at least one manually adjustable articulated joint in a set position is provided.

8. The device according to claim 6, wherein the at least one manually adjustable articulated joint is configured so that the first holder assembly is adjustable about six degrees of freedom via the first arm assembly.

9. A device for repositioning bone fracture fragments, comprising: a carrier assembly; a first arm assembly attached to the carrier assembly, he first arm assembly configured to hold a first bone fracture fragment; a second arm assembly attached to the carrier assembly, the second arm assembly configured to hold a second bone fracture fragment; an actuator assembly configured to adjust the second arm assembly; and an operating assembly configured to control an adjustment of the second assembly via the actuator assembly; wherein the carrier assembly includes a rail member; wherein the second arm assembly includes a slide member hat is disposed on the rail member; and wherein via the actuator assembly the slide member is moveable in a longitudinal direction of the rail member.

10. The device according to claim 9, actuator assembly includes a first motor configured to move the slide member.

11. The device according o claim 9, wherein the second arm assembly has a plurality of articulated joints, each of the plurality of articulated joints being moved by one of a plurality of motors.

12. The device according to claim 9, wherein: the second arm assembly includes a first articulated joint, a second articulated joint, a third articulated joint, a first connection plate, and a second connection plate; the first articulated joint is disposed on the slide member; the first connection plate is disposed between the first articulated joint and the second articulated joint; and the second connection plate is disposed between the second articulated joint and the third articulated joint.

13. The device according to claim 12, wherein a holler assembly is disposed on the third articulated joint.

14. The device according to claim 12, wherein the operating assembly is disposed in a region of the third articulated joint.

15. The device according to claim 12, wherein: the first articulated joint has a first axis of rotation and the second articulated joint has a second axis of rotation; and the first axis of rotation and the second axis of rotation are parallel to each other.

16. The device according to claim 12, wherein the third articulated joint has three axes of rotation arranged orthogonally relative to each other

17. An operating table, comprising: a device for repositioning bone fracture fragments, including: a carrier assembly including a fastening assembly; a first arm assembly attached to the carrier assembly, the first arm assembly configured to hold a first bone fracture fragment; a second arm assembly attached to the carrier assembly, the second arm assembly configured to hold a second bone fracture fragment; an actuator assembly configured to adjust the second arm assembly; and an operating assembly configured to control an adjustment of the second arm assembly via the actuator assembly; wherein the operating assembly is a manually operatable operating assembly; and wherein the device for repositioning bone fracture fragments is detachably fastened to the operating table via the fastening assembly.

18. The device according to claim 17, wherein the fastening assembly is a friction-type fastening assembly.

19. The device according to claim 17, wherein a patient upper leg cushion or a patient lower leg cushion is detachably fastened to the carrier assembly.

20. The device according to claim 17, wherein the operating assembly is a joystick having six degrees of freedom.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Further features and advantages of the disclosure are set out in the following description which illustrates exemplary embodiments of the present disclosure.

[0038] FIG. 1. shows a schematic, perspective view of an exemplary device for repositioning bone fracture fragments.

[0039] FIG. 2 shows a further schematic, perspective view of the exemplary device in accordance with FIG. 1.

[0040] FIG. 3 shows a further schematic, perspective view of the exemplary device in accordance with FIGS. 1 and 2.

[0041] FIG. 4 shows a schematic view of an arrangement with a section of an operating table and the exemplary device in accordance with FIGS. 1 to 3.

[0042] FIG. 5 shows a view from above of the arrangement in FIG. 4.

[0043] FIG. 6 shows a view from above of the arrangement in FIGS. 4 and 5 with changed orientation of the device for repositioning the bone fracture fragments.

[0044] FIG. 7 shows a schematic, perspective view of the arrangement in accordance with FIG. 5.

[0045] FIG. 8 shows a further schematic, perspective view of the arrangement in accordance with FIGS. 4 to 6 with the upper leg cushion in place.

[0046] FIG. 9 shows a schematic, perspective view of the arrangement in accordance with. FIGS. 4 to 8 with the upper leg cushion and lower leg cushion in place.

[0047] FIG. 10 shows a perspective detailed view of the exemplary device in accordance with FIGS. 1 to 3.

[0048] FIG. 11 shows a further perspective detailed view of the exemplary device in accordance with FIGS. 1 and 3.

[0049] FIG. 12 shows a further detailed view of the exemplary device in accordance with FIGS. 1 to 3.

[0050] FIG. 13 shows a sequence plan for controlling the actuators for repositioning bone fracture fragments.

DETAILED DESCRIPTION AND INDUSTRIAL APPLICABILITY

[0051] FIGS. 1 to 3 each show a schematic, perspective view of a device 10 for repositioning bone fracture fragments.

[0052] In fractures of human bones, more particularly of large hollow bones, the fragments are aligned/repositioned with regard to each other. Only after this has been done can the bone fragments be fixed by, for example, plates and/or intramedullary nails. For repositioning the bone fracture fragments, the device 10 may comprise a first arm assembly (e.g., first arm 12) as well as a second arm assembly (e.g., second arm 14), a first end of each of which is attached to a carrier assembly (e.g., carrier unit 16). On the end portions (e.g., ends) opposite the carrier unit 16, a respective holder assembly (e.g., holder unit 18, 20) may be arranged, to which Schanz screws inserted into the bone fracture fragments can be fastened.

[0053] Initially, the Schanz screws of a first bone fracture fragment may be fastened to the first arm 12, for example to the first holder unit 18. The first holder unit 18, and thereby the first bone fracture fragment attached to it, may then be brought into the desired position. For this the first arm 12 may have three articulated joints 22, 24, 26 which may be manually adjustable. More particularly, the articulated joints 22, 24, 26 may be designed so that the first holder unit 18, and hence the bone fracture fragment attached to it, can be moved all three spatial directions as well as turned in three directions. In this way the alignment of the first bone fracture fragment can be changed as desired.

[0054] The second bone fracture fragment may then be attached via Schanz screws to the second holder unit 20 and aligned with the help of the second arm 14.

[0055] The second arm 14 may have three articulated joints 32, 34, 36, via which the position and alignment of the second holder element 20 can be varied.

[0056] The first articulated joint 32 may be a unidirectional joint that enables rotation about a first axis of rotation 38. The second articulated joint 34 may also be unidirectional and may allow rotation bout a second rotational axis 40. A first connection plate 42 may be arranged between the first and the second articulated joint.

[0057] In addition, a second connection plate 44 may be arranged on the second articulated joint 40, via which the second articulated joint 34 may be articulately connected to the first connection plate 42. Arranged on the end of the second connection plate 44 facing away from the second articulated joint may be the third articulated joint 36.

[0058] The third articulated joint 36 may be designed as an articulated joint assembly with three separately-driven individual articulated joints, so that the articulated joint 36 may allow rotation about three axes of rotation 50, 52, 54 arranged orthogonally with regard to each other.

[0059] For example, the axes of rotation 38, 40 and 50 may be arranged in parallel with each other. For example, via the three articulated joints 32 to 36, adjustment about five degrees of freedom may be provided.

[0060] In order to also allow adjustment about the sixth degree of freedom, the end of the second arm 14 facing away from the second holder unit 20 may be disposed (e.g., arranged) on a slide member (e.g., slide) which can be moved on a. rail member (e.g., rail) of the carrier unit 16 in the direction of the double arrow P1.

[0061] Both the movement of the second arm 14 on the rail of the carrier unit 16 and the adjustment of the articulated joints 32 to 36 may take place via electric actuators which may be controlled by an actuator assembly (e.g., an actuator unit 56 such as for example an electric actuator unit, a hydraulic actuator unit, or a motorized or mechanical actuator unit).

[0062] In at least some exemplary embodiments, the first articulated joint 32 and/or the second articulated joint 34 can also be in the form of an articulated joint assembly so that movement about more than one axis of rotation may be possible for these joints.

[0063] In addition to the mechanical assembly described and shown in the figures, the device 10 may comprise a control and operating unit with an operating assembly (e.g., an operating element 60). the actuator unit 56 and the electric actuators. The electric actuators may each have suitable motor transmission combinations. More particularly, a first electric actuator for moving the second arm 14 on the rail of the carrier unit 16 may be provided. In addition, five further electric actuators may be present, wherein each of these actuators is for adjusting one of the articulated joints 32 to 36 and arranged directly on it.

[0064] Furthermore, arranged on the end of the second arm 14 on which the holder unit 20 is also arranged, may be an operating element 60 via which the (e.g., electric, hydraulic, or mechanical) actuator unit 56 is controlled, so that via this operating element 60 the adjustment of the second arm 14 can be controlled by the operator.

[0065] The operating element 60 may be a 6 DoF (degrees of freedom) sensor, which itself can be operated in six degrees of freedom, wherein on operation of the sensor about one of these degrees of freedom the second arm may be moved accordingly, so that intuitive control is possible.

[0066] The cap of the operating element 60 can, for example, be moved in the direction of the three axes 50, 52, 54, which may result in a corresponding movement of the second holder unit 20 and thus of the second bone fracture fragment. In addition, the cap can be turned and tilted in two directions, which may be converted into a corresponding rotary movement.

[0067] Depending on which treatment of the fracture may be being carried out, different positioning of the broken extremity before, during and after the operation may occur. For example, various cushions can be applied to and also removed from the carrier unit 16. This may be advantageous in order to allow intraoperative access to the fracture and to remove objects that negatively affect the X-ray image to be removed from the direct radiation beam.

[0068] For example as shown in FIG. 1, no cushion is fastened to the carrier unit 16. In the embodiment shown in FIG. 2, also for example, a lower leg cushion 62 may be provided. The embodiment in FIG. 3 shows an upper leg cushion 64 (e.g., firmly) fastened to the carrier unit 16. Alternatively for example, both cushions 62, 64 can be provided.

[0069] As shown in FIGS. 4 to 9, the device 10 can be fastened to an operating table 100. For this, the device 10 may have a fastening assembly (e.g., fastening unit 70), which, in particular, allows articulated fastening to the operating table 100 by a friction-type connection.

[0070] As can be seen in FIGS. 5 and 6, the connection between the operating table 100 and the device 10 may be such that swiveling of the device 10 is possible, so that the leg placed on it can be positioned accordingly.

[0071] In FIGS. 7 to 9, further embodiments are shown, wherein a different exemplary combination of the applied cushions 62, 64 is shown in each embodiment

[0072] FIGS. 10 to 12 each show detailed exemplary views of the device 10, wherein in FIG. 10 the second arm 14, a part of the carrier unit 16 and the rail of the carrier unit 16 are shown. FIGS. 11 and 12 each show the third articulated joint 36 as well as the second holding unit 20. A component of the device may be a linear track. The linear track may be aligned with its main axis along the X-axis of the coordinate system of the device 10. The Y-axis, which may be perpendicular to the X-axis, may point in the depth direction. The Z-axis, perpendicular to the other two axes, may point upwards.

[0073] The track may comprise a support structure 129 with flanged-on terminals 130, 131 at both ends. Running between these terminals may be two guide rails 128 on which a slide 183 moves. The slide 183 may be driven by the threaded rod 132. The rotation of the threaded rod 132 may be converted by a threaded sleeve incorporated in the slide 183 into a self-inhibiting translation. The threaded rod 132 may end on one side of the support structure in a bearing which is located in one of the two terminals 130, 131. The other terminal 130 may also he designed in substantially the same way, but to a certain extent may give the spindle clearance to the outside. On this part of the spindle, an end piece of an Oldham coupling 148 may be clamped on. The other end of the coupling may be clamped to the shaft of an electric motor 312. The motor 312 may he fastened in mechanical dampers 149. These, in turn, may be attached to a holder structure 136 including three plates perpendicular to each other. The holder structure may be screwed to the outer side of the terminal 130 which may assure access to the spindle. In this way, through rotation of the motor axle, the slide 183 can be moved linearly along the spindle axle.

[0074] Attached to the slide 183 may be a multiple-joint arm structure which may allow the holder unit 20 attached to the end effector to move in 5 degrees of freedom. Preferably, the first three axes of the articulated arm may be aligned in parallel. With these three axes, three of the degrees of freedom can already be set.

[0075] A bottom place (e.g., location) may be attached to the slide and perpendicularly thereto a. base plate 184. It may comprise a gear module 187, Which may be driven by an electric motor 310 and may have an integrated cross-roller bearing for diverting the forces and torques and may constitute the articulated joint 32. The plate structure 220 may be mounted on the end face of the gear output. Accommodated in a recess, this plate may have the circuit board 264 of the angle measuring system belonging to the articulated joint 32. At the upper end of the plate 220, there may be an electric motor 308 of the second articulated joint 34 on the same side as the gear output of the basic articulated joint 32. This may be attached by a flanged plate. Attached on the opposite side of the plate 220 may be the gear mechanism of the articulated joint 34. This may also be in contact with the end surface of the gear output on the plate 220. The plate 230 may be applied to the end surface of the drive of the gear mechanism. The board of the angle measuring system of articulated joint 34 may also be located in a corresponding recess on the other side of the plate 230, relative to the recess of the first-mentioned angle measuring system.

[0076] On the upper side of the plate 230, an electric motor 302 may be attached in the same alignment as the electric motor 308 of the articulated joint 34 by a flanged plate. In a position (e.g., substantially the same position) on the plate 230 on the opposite side, the output of the gear mechanism 187 of the articulated joints 36 may be fixed with its end surface on the plate 230. On the end surface of the drive wheel 187, a mounting plate 236 may be applied.

[0077] Attached to this at a right angle on the side of the gear mechanism 187 may be a further plate 237. This may provide a mounting for the, gear mechanism 187 that may be used downwards on the Z-axis of the device 10. Attached above this gear mechanism 187 by an adapter flange 245 may be a further electric motor 304 for actuating the articulated joint 36.

[0078] Furthermore, above the motor 304, a 6 DoF sensor with an operating element may be attached on a platform 251. The alignment of its axes corresponds to the arrangement of the X-axis, Y-axis and Z-axis of the device 10 in the normal state.

[0079] Under the gear mechanism 187 of the Z-axis, a mounting plate 256 may be perpendicularly attached on the end surface of the gear output. On its rear, the plate 256 may accommodate an electric motor 306 by a flanged plate. The shaft of this may be non-rotatably connected to a gear mechanism, the drive wheel of which may be fastened to the end surface of mounting plate 256. This combination may cause an adjustment of the articulated joint 36 about the Y-axis. On the output wheel of the latter gear mechanism may be a mounting plate 263, which may constitute the mechanical connection for the pin holder. The pin holder may initially include an external fixator configuration. This may include two rods 158 to which two Schanz screws 182 may be clamped by special clamping jaws 164. The two basic holders may be applied in a parallel manner. For example, the Schanz screws may be fixed in the clamping jaws perpendicularly to the two basic rods in a plane parallel to the plane through the two basic carriers.

[0080] Both Schanz screws may be screwed into the distal femur segment 272. For example, in the case of intramedullary nailing, the Schanz screws close to the fracture gap can be inserted mono-cortically. For insertion of the nail the medullary space may be free of obstacles.

[0081] To hold the basic rod system, the device 10 may have a clamping jaw holder, comprising a mountable cap 157 and a base plate 156 into which the cap 157 may be screwed.

[0082] By a transition piece 265, the base plate 156 may be attached on its underside at right angles to the mounting plate 263. For this, the transition piece 265 may have three drilled holes for assembly on said mounting plate 263 and two drilled holes perpendicular thereto for assembly of the base plate 156 of the pin holder.

[0083] FIG. 13 illustrates a sequence plan for controlling the actuators for repositioning bone fracture fragments. In connection with operating input by way of the operating element 60, ISD data may be generated which are then converted into 3D data. When the device 10 is in operation, through applying power to the motors and through braking, a holding torque may be exerted in each articulated joint 32, 34, 36. This may result in (e.g., permanent) holding of the position and orientation of the pin holder and the Schanz screws connected thereto. For example, this also may result in the (e.g., permanent) retention of the distal femur fragment. If the user changes the position or orientation of the cap of the 6 DoF sensor, this may be converted into a movement. For example, operation by a user may be provided in a manner that is intuitive for the user.

[0084] If the user desires a translation of the pin holder in the positive X-direction, the user may push the operating element 60 with the cap 254 in this direction (e.g., via the user's hand on top of it). In this case, the user may directly implement control of the motor on the spindle. If the user desires a translation in the Z or Y-direction, the user may push the cap in one of these directions. This action may be implemented by the articulated joint arm structure. At this time, an inverse situation is involved. The translation that is known may be recorded in the 6 DoF sensor, but the angle settings are individually calculated. For this, an iterative process such as FABRIK may be used. The translation desired by the user may be delivered (e.g., as unit-less) by the sensor and converted into a speed. For the known duration of controlling the motor, the travelled path may be calculated and added to the position of the target point.

[0085] For controlling the motors 302 to 312, a speed trajectory may be generated. This may include a linear acceleration phase with a defined gradient until the maximum speed may be reached. It may be held until a linear deceleration ramp with a defined gradient sets in and the speed has fallen (e.g., fallen to zero

[0086] If the user continues to maintain an input during the movement of the system, the start of the deceleration ramp may be recalculated and may be started correspondingly later if it has not for example yet been reached. If the system is already in the deceleration phase, an acceleration ramp suitable for reaching the maximum speed with a defined gradient may be calculated and implemented. If the user ends an entry, the previously calculated movement trajectory may run until completion. Thereafter the achieved positioning may be held (e.g., permanently held). The same procedure may apply to changing the alignment of the end effector. For example, the user may turn the cap 254 about at least one of the axes. If this is a rotation about the Y-axis or Z-axisdesignated My and Mzthe relevant drive unit 302 to 306 of the articulated joint 36 may be directly actuated.

[0087] However, if this is a rotation about the X-axis designated Mx, for example by the FABRIK algorithm a new configuration of the angle settings of the articulated arm may be calculated. The participating articulated joints may then be actuated as described. On completion of the process, the alignment and position of the end effector may be in turn held without user input.

[0088] An exemplary intraoperative use of the device 10 may take place as follows. First, the operator may fit each fragment with (e.g., two) Schanz screws. These can for example be inserted in one plane, and may or may not be parallel to each other. In addition, one screw may be inserted close (e.g., quite close) to the fracture gap and one screw (e.g., relatively far away) away from the fracture gap. In accordance with the procedure of applying an external fixator, the screws may be clamped onto two parallel rods with special clamping jaws. Via a clamp mounting, these rods may then be clamped onto the holder on the end effector of the relevant articulated arm.

[0089] Upon completion of these measures, the device 10 can be positioned and fixed on the operating table. Alternatively the device 10 can be fixed to the operating table before the start of positioning and at that point brought into operation. The passive, first articulated arm may be initially brought into position and manually fixed. The active, second articulated arm may then be moved into the desired position through input via the sensor element. Via the screw clamping, the rods of the external fixator configuration may be connected with the end effector of the relevant articulated arm. For this, the rods may be moved into the basic shell of the clamping device, the clamping cap may be positioned above them and both may be pulled toward each other through turning of the centrally arranged screw.

[0090] If a play-free mechanical clamping connection is created, the operator can loosen individual joints of the passive arm and newly align the proximal fragment. After suitable (e.g., satisfactory) alignment, the arm may be completely fixed. The thus produced retention of the position and orientation of the proximal fragment may serve as a reference for the alignment and positioning of the distal fragment. For this, the operator may use the motorized articulated arm and may change the alignment and position of the end effector through acting on the sensor cap by the user's hand placed on it. After suitable (e.g., satisfactory) alignment, the operator may release the sensor. The device now may keep the set position and orientation constant. By way of for example X-ray imaging, the operator can check the suitability of the repositioning. Therein, for protection against radiation exposure, the entire operating team can assume a suitable (e.g., certain or predetermined) distance from the radiation beam. After evaluation of the produced images, corrections can be carried out through renewed positioning. On completion of the positioning, the guide wire can be introduced and, if applicable, the medullary space drilled open. If nail application is being carried out without drilling open and without guide wire, the nail can inserted at this point. After the nail has passed the fracture gap the device is removed. This may be done in reverse order to the application of the device. First, the clamping connection with the device with the external fixator may be loosened, and the Schanz screws may then be removed. Finally, the procedure may then be ended in that the nail is fully inserted in a suitable manner, locked, and the closing cap applied (e.g., if appropriate) and wounds may be closed. When plating the fragments, the device may remain in place during this stage of treatment. Through the above-described device, an increase in the precision of positioning the bone may be achieved,

[0091] In at least some exemplary embodiments, parts of the operator's body may not remain in the radiation beam of an X-ray device during the process of producing the X-ray images. Furthermore, the operator may be able to intuitively control the described system.

[0092] Although robotic systems may be controlled by joysticks firmly fixed in space, in at least some exemplary embodiments the sensor may be located directly on the end effector. For example, the surgeon or the assistant physician may cover with one hand the area of the extremity is distal of the fracture and with the other hand the sensor element which is arranged (e.g., very close) close to the extremity and undergoes no movement relative to the extremity. In this way, the physician can move the area of the extremity in the same way as he would do without using the device. This procedure is intuitive and does not require long learning/training times/efforts by operators. A further advantage may be that the physician has a hand on the extremity at some, most, or all times and therefore may receive (e.g., permanent) haptic feedback in the same way as the user would in purely manual repositioning, with the advantage that no high tensile forces are applied to the extremity. Through the de-coupling of the high tensile force produced by the patient's muscles, very delicate and precise work can be carried out, which is associated with a better outcome. Moreover, the device 10 may be portable, small and light in weight, can be mounted on the universal rail of an operating table or the leg plate interface of an operating table and may allow integration into leg plates.

[0093] Device 10 may involve no navigation and/or initialization, no current CT data for the patient and no specially-trained personnel. Over and beyond this, the method is considerably less costly and time-consuming and allows intuitive control of the system.

[0094] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed method and apparatus. Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the disclosed method and apparatus. It is intended that the specification and the disclosed examples be considered as exemplary only, with a true scope being indicated by the following claims.