HANDHELD SURGICAL TOOL WITH AUTONOMOUS NAVIGATION

Abstract

A handheld surgical tool includes a handle, an instrument shaft, and a navigation device, which includes at least one sensor unit for sensing positional data, a computing unit configured to determine a position in space based on signals of the sensor unit, at least one set key and a position memory configured to store a data set for a position upon activation of the at least one set key. A comparator is operatively connected to the position memory for comparing an actual position against a stored position in at least two different operation modes and for generation of a deviation signal, wherein operation modes differ in that a first mode is configured for a reduced comparison only which lacks at least one spatial dimension. A feedback device is provided supplied with the deviation signal and being configured to indicate direction and preferably magnitude of any deviation.

Claims

1. A handheld surgical tool comprising: a handle, an instrument shaft, a navigation device, the navigation device comprising at least one sensor unit for sensing positional data, a computing unit configured to determine a position in space based on signals of the sensor unit, at least one set key, and a position memory configured to store a data set for a position upon activation of the at least one set key, a comparator operatively connected to the position memory, the comparator being configured for comparing an actual position against a position stored in the position memory in at least two different operation modes and for generation of a deviation signal, wherein a first operation mode differs from a second operation mode in that the first operation mode is configured for a reduced comparison that lacks at least one spatial dimension that the second operation mode does not lack, and a feedback device for receiving the deviation signal, the feedback device being configured to indicate direction of any deviation.

2. The handheld surgical tool of claim 1, wherein the feedback device is configured to suppress indication of the at least one spatial dimension in the first operation mode.

3. The handheld surgical tool of claim 1, wherein the feedback device is configured to indicate the deviation qualitatively.

4. The handheld surgical tool of claim 1, wherein the feedback device comprises a tolerance module that is configured to suppress indication of a deviation below a presetable threshold.

5. The handheld surgical tool of claim 1, wherein the feedback device is a two-part construction, having an indicator located remotely.

6. The handheld surgical tool of claim 1, comprising a remote display for indication.

7. The handheld surgical tool of claim 1, comprising a reference base provided at an exterior surface of the surgical tool.

8. The handheld surgical tool of claim 1, where in comprising an offset device that is configured to determine a position of a tip of the instrument shaft and a position of another instrument attached to the instrument shaft.

9. The handheld surgical tool of claim 1, wherein the position memory is a duplex memory having a first memory unit and a second memory unit, wherein the second memory unit is configured for storing a full data set for the position forming a full position indication, and the first memory unit is configured for storing a subset only, wherein the subset lacks data for at least one degree of freedom in the position in space to form an incomplete position indication.

10. The handheld surgical tool of claim 1, comprising a rechargeable battery operatively connected to a wireless charging unit.

11. The handheld surgical tool of claim 1, wherein the set key comprises a momentary switch, a sensor switch or a voice controlled switch.

12. The handheld surgical tool of claim 1, wherein the sensor unit comprises accelerometers, rate gyroscopes, or magnetometers.

13. The handheld surgical tool of claim 1, comprising an interface configured to supply positional data of the handheld surgical tool to an external system.

14. A method for orienting a handheld surgical tool with autonomous navigation, the handheld surgical tool comprising a handle, an instrument shaft and a navigation device, the navigation device comprising at least one sensor unit for sensing positional data, a computing unit configured to determine a position in space based on signals of the sensor unit, at least one set key and a position memory configured to store a data set for a position upon activation of the at least one set key, and a comparator operatively connected to the position memory, the method comprising: storing in the position memory full positional data and a subset of positional data, wherein the subset of positional data lacks at least one spatial dimension, comparing an actual position against a position stored in the position memory using the subset of positional data in a first operation mode, generating a first deviation signal based on a result of the comparison, switching to a second operation mode by command, comparing an actual position against a position stored in the position memory using the full positional data, providing a feedback about direction of any deviation to the user in the first operation mode and in the second operation mode.

15. (canceled)

16. The handheld surgical tool of claim 1, wherein the feedback device is configured to indicate magnitude of any deviation.

17. The handheld surgical tool of claim 1, wherein the feedback device is configured to indicate the deviation non-numerically.

18. The handheld surgical tool of claim 1, wherein the feedback device is configured to indicate the deviation by at least one of a visual, an aural, and a tactile indication.

19. The handheld surgical tool of claim 5, wherein the indicator is located on a separate display.

20. The handheld surgical tool of claim 6, wherein the remote display is a hybrid display for showing imagery of a patient.

21. The handheld surgical tool of claim 7, comprising a key configured for zeroing the navigation device.

22. The handheld surgical tool of claim 1, comprising an offset device that is configured to determine a position of a tip of the instrument shaft or a position of another instrument attached to the instrument shaft.

23. The handheld surgical tool of claim 12, wherein the sensor unit comprises sensors in at least a 3-axis configuration.

24. The method of claim 14, comprising providing a feedback about magnitude of any deviation to the user in the first operation mode and in the second operation mode.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The invention will further be described in more detail with the regard to accompanying drawing. The figures of the drawing show:

[0031] FIG. 1: a side view of a preferred embodiment of the invention;

[0032] FIG. 2: a schematic view showing function blocks of the preferred embodiment of FIG. 1;

[0033] FIG. 3: an example for a feedback device using a visual indication;

[0034] FIG. 4a, b: an overview of a C-arm placed at an operational table in a first orientation and a detailed view of a part of the spinal column of a patient;

[0035] FIG. 5a, b: an overview similar to FIG. 4 but with the C-arm in a different orientation and the corresponding detail view of the spinal column; and

[0036] FIG. 6a, b: detailed views in two different orientations like in FIGS. 4 and 5 for a different application.

DETAILED DESCRIPTION OF THE INVENTION

[0037] A preferred embodiment for a handheld surgical tool according to the present invention is shown in FIG. 1. The surgical tool comprises as main components a handle 1, an instrument shaft 2 and a navigation device 3. The instrument shaft 2 in this depicted embodiment is a wire guide having an internal hollow conduit for guiding a surgical wire to be placed at a bone. In order to place the surgical wire in a correct manner, the wire guide must be placed with its tip on the target location in a certain orientation which determine the angle with which the wire will enter the bone material. The wire guide may be exchanged against other instruments if desired.

[0038] The navigation device 3 is in the depicted embodiment releasably connected to the handle 1 by means of connecting splints 13. It is to be noted that such a detachable configuration is an option and the navigation device 3 may well be integrated into the handle 1, alternatively.

[0039] A functional explanation of the handheld surgical tool according to the preferred embodiment will be given with reference to FIGS. 2 and 3. The navigation device 3 comprises at least one (in the depicted embodiment three different) sets of sensor units 31, 31′, 31″, the sensor units being a 3-axis accelerometer, 3-axis rate gyroscopes and a 3-axis magnetometer, respectively. Each sensor unit 31, 31′, 31″ on its own produces positional information independently from each other, said positional information comprising e.g. acceleration or other positional data from yaw, roll and pitch reference to the body frame of the handheld surgical tool. The three sensor units 31, 31′, 31″ are connected to a data fusion module 32. It is configured to process the output signals of the sensor units in a generally known manner (filtering, normalizing, calibrating etc.) and further to merge the processed signals in order to produce a unified consolidated position output signal. For this merging generally known techniques are used (like Kalman-filter, Quaternion-gradient, or complementary filter etc.). Optionally, the data fusion module 32 is further configured to code the output by Quaternions in order to avoid gimbal lock issues.

[0040] The consolidated output position signal of the data fusion module 32 is applied to the computing unit 33. Based on this signal a conversion to Euler angles is performed by successive projection on the planes of a 3D-Euclidean space, thereby forming a trajectory definition. The trajectory definition which is defined by e.g. angles for yaw and pitch can be stored in a position memory 36.

[0041] The position memory 36 comprises a first memory unit 37 and a second memory unit 38. The second memory unit 38 is configured for storing a full data set for the position as determined by the computing unit 33. In contrast, the first memory unit 37 is configured for storing of a subset of the position data set only, wherein the subset lacks data for at least one degree of freedom regarding the spatial position of the instrument. In the preferred embodiment, that degree of freedom for which data is lacking may be the pitch angle. Storing and recalling of data into and from the first and second memory unit 37, 38 is controlled by the selector 39 which is operatively connected to set key 35 which is further connected to a comparator 4.

[0042] As an alternative to the set key 35, a microphone 35′ may be provided. Thereby, a voice activation could be substituted for physical pressing of the set key 35. Speaking a command word like “freeze” may thus substitute pressing of the set key in order to lock in heading/pitch as desired.

[0043] The comparator 4 is operatively connected to the position memory 36, the computing unit 33 and to the set key 35. Further, it is configured to recall data from the first memory unit 37 or the second memory unit 38 depending on an operation mode. The operator 4 is configured for two operation notes. The operation mode may be selected by the set key 35. In a first operation mode, the comparator 4 is configured to recall the stored incomplete position from the first memory unit 37 and to compare it against an actual position indication as supplied by the navigation computing unit 33. Based on the difference between these position indications, the comparator 4 generates a first deviation signal for one special direction, namely yaw in the preferred embodiment. In the second operation mode, the comparator 4 is configured to recall the full position indication from the second memory unit 38 and to compare it against the actual position indication as supplied by the computing unit 33. Based on the difference between these position indications it generates a second deviation signal which has one more dimension than the first deviation signal, namely yaw and pitch in the preferred embodiment. Switching from the first to the second operation mode is controlled by the user by means of set key 35.

[0044] Further, a feedback device 5 is provided to which the first and second deviation signal is supplied. The feedback device 5 is configured to indicate direction—and in a qualitative manner magnitude of any deviation as defined by the first or second deviation signal. In the preferred embodiment, the feedback device is configured for a tactile indicator 52, an aural indicator 53. Further, as part of a two-piece construction a visual indicator is provided, the visual indicator being formed by a display 54 of a separate device. The display 54 forming the visual indicator comprises two orthogonal growths of lighted dots arranged in a crosshair pattern (see FIG. 3). The tactile indicator 52 comprises two pairs of vibration transducers 52′ and 52″ arranged on opposite lateral sides of the handle 1 and on the top and bottom side of the handle 1, respectively. As an aural indicator a loudspeaker 53 is provided which is driven by a sound module 53′ forming a part of the feedback device 5. Further, the feedback device 5 is configured with a wireless transmitter 58 configured for communication with a remote display, which can be a tablet computer, and/or other navigation systems present in the operation theatre.

[0045] Further, an offset device 6 is provided. It is configured to determine the position of a tip of the instrument 2 attached to the handle 1. Data regarding a distance between a tip 21 and the sensors 31, 31′, 31″ of the navigation device 3 and the angle at which the instrument 2 is orientated against the handle 1 is preset in the offset device 6. Thereby the offset device 6 is enabled to modify position indications of the navigation unit 33 such that it is the position of the tip 21 which is the base for triggering the feedback device 5 rather than a position of the navigation device 3 proper. The offset device 6 needs to be adjusted if a different instrument 2 having a different length or being angled differently is to be attached. To this effect setting means (not shown) are provided.

[0046] Yet further, a rechargeable battery 7 is provided which supplies the various components of the handheld surgical tool. The supply lines are not shown FIG. 2. In order to recharge the battery 7 a recharging coil 71 is provided which is configured for wireless charging.

[0047] Operation of the handheld surgical tool and its indications as effected by the feedback device 5 will be described in the following.

[0048] As a first step, the user will place the instrument on a flat surface, preferably the operation table. The instrument shall be placed with the reference base 30 at the bottom of the navigation device 3 flat on the table. This defines a zero position and is acknowledged by pressing of a zero set knob 34. This sets a body frame of the instrument which a reference frame of the operating room.

[0049] In a second step, the user will take the instrument and place it at a desired position. Positioning will be performed under fluoroscopic control as effected by a C-arm 88. For the sake of discussion it shall be assumed that the C-arm is oriented vertically, such as to provide a view along an A/P direction of a patient placed on the operating table 89 (see FIG. 4). The fluoroscopic view may be presented to the surgery team by means of a conventional observation screen device 8 (see FIG. 5). The fluoroscopic view achieved in the situation is shown in FIG. 4b.

[0050] By means of definition, a coordinate system for the human body shall be defined featuring an X-axis as side to side, a Y-axis as up and down, and a Z-axis orthogonal to the X- and Y-axis indicating depth. Thereby, an anterior-posterior view as achieved in FIG. 4 provides information regarding a trajectory relative to the X/Y-plane. In this view, the cephalo-caudal and medial-lateral orientation can be appreciated, as the surgeon will be able to see the defined starting point (marked by a small circle at the begin of a dashed line in FIGS. 4b and 5b) of the guidewire (or stymen pin, screw, etc.) as well as the endpoint of the desired trajectory (marked by a star symbol at the end of the dashed line in FIGS. 4b and 5b). For example, for a translaminar facet screw, the desired endpoint on the AP view would be the infero-lateral cortex of the pedicle. The line between the defined starting point and the desired endpoint can be calculated as an angle or trajectory relative to the X-axis and the Y-axis. Once the targeting instrument is moved with its tip 21 to the starting point and is oriented towards the desired endpoint, the surgeon will be able to press the set key 35 (or alert the system verbally) to confirm acceptance of this trajectory as illustrated in FIG. 4b. It is to be noted that the targeting instrument itself remains outside of the human body and the orienting happens outside of the human body.

[0051] When this trajectory is accepted by the surgeon, the navigation device 3 stores the corresponding positional data set upon pressing of the set key 35 in the first memory unit 37. This sets a first angle, e.g. yaw for the preferred embodiment. As long as the handheld surgical tool is held by the surgeon with the correct yaw angle (heading), an indication will be provided by the feedback device 5 similar to that of FIG. 3a. In case that a yaw error were to occur, then the light would wander along the horizontal axis depending on the magnitude of the heading deviation. For example, FIG. 3b shows a mild (but no longer tolerable) deviation to the left. Thereby, the yaw position is locked-in, and the surgeon can find it again by reference to the visual indication and by re-centering it such as to get an indication as shown in FIG. 3a. It is to be noted that no pitch angle information is shown. This is supressed since this is the one spatial dimension by which the first operation mode is reduced. By supressing this information focusing of the surgeon to achieving a proper pitch angle is facilitated, since the navigation device automatically monitors maintaining of proper yaw angle and indicates just any yaw deviations.

[0052] As a next step, the pitch angle is to be set. The surgeon then moves the handheld surgical tool into the desired pitch position, as verified by the fluoroscopic view generated by the C-arm 88 now moved in a position orthogonal to the previous one (see FIG. 5). Once it is ascertained that the pitch angle is proper, and still the desired heading angle is maintained, the surgeon will press the set key 35 again. The comparator 4 then switches into the second operating mode. In this mode the trajectory of the surgical tool is fully “locked-in”. Any deviation of the instrument from that selected position, either in pitch or in yaw or both, will be detected by the comparator 4 in said second operating mode and will be shown by the feedback device 5. For example, a serious deviation to the right and a mild (but no longer tolerable) deviation upwards is indicated in FIG. 3d. The surgeon needs to adjust both, yaw and pitch, in order to regain the desired trajectory, and once he has accomplished this indication like that in FIG. 3c will be given.

[0053] In order to avoid an oversensitive action of the feedback device, a tolerance module 51 is provided. It is set to a tolerance criteria defining an individual level of tolerance for each angle. Examples for tolerance angle may be a maximum of two degrees.

[0054] The invention has application for any screw trajectory, and another example would be for placement of pedicle screws. FIGS. 4b and 5b illustrate the radiographic landmarks which would be used for pedicle screws placed in a “cortical” trajectory. The starting point in the AP plane is defined as the empty space between the pedicle and an imaginary box drawn around the pedicle, shown as a small circle in FIG. 4b. The endpoint would be the superior-lateral aspect of the pedicle near the junction of the vertebral body, as shown by a star in FIG. 4b. These are well-known landmarks which can be used by the surgeon to choose a trajectory in the AP plane.

[0055] Further, in addition to the visual indication as provided by the display 54 (see FIG. 3a-d), aural and/or tactile indications can be given to the surgeon. For the tactile indication, vibration actuators in the left and right lateral side and in the upper and bottom section of the handle 1 will be activated as necessary in order to indicate a deviation to the left or right or to the top and to the down direction. A correct position will be achieved when all vibration actuators will be silenced. The strength of the activity of the vibration actuator may indicate a degree of deviation. Similarly, an aural indication can be given by the loudspeaker 53 (which may also be an earpiece). The control unit 53′ is configured to vary pitch of a tone depending on a pitch deviation, like going to a higher tone if the pitch angle is too high and going to a lower tone if the pitch angle will be too low. Further, a continuous tone will be emitted if the heading is centered, the continuous tone becoming like a series of dashes if a deviation to the left will be detected and will become a series of dots if a deviation to the right will be detected, gradually blending over to a continuous tone as soon as the centered position will be regained. Thereby the surgeon can re-center the position and maintain the original trajectory without having even to look.

[0056] It is to be noted that the display 54 can preferably be on a different device as part of a two-piece construction. The different device may be a handheld or tablet computer. Thereby, an inexpensive and very efficient means is provided to give visual indication to the surgeon and his team.